U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Accelerator, linear, medical - Product Code IYE
Reason
Uncontrolled couch z-axis movement (descent).
Action
Accuray sent an Urgent Field Safety Notice letter dated November 8, 2017, to affected customers. The letter identified the affected product, problem and actions to be taken.
The letter stated the following:
"Accuray(R) will correct all affected High-Performance Patient Couches. An Accuray representative will contact you to arrange a time to update your system. The update includes the installation of TomoTherapy(R)' H(TM) Series
software version 2.1.2 (Hi ¿Art(R) vS.1.2) on your system, as well as the replacement of cables within the couch subsystem."
For questions contact Accuray Customer Support by phoning the regional support lines.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Bit, drill - Product Code HTW
Reason
One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm).
Action
MicroAire Surgical Instruments, LLC distributed recall letters on May 22, 2017
MicroAire Surgical Instruments, LLC distributed recall letters to the customers who received the mislabeled twist. Letters will be sent by UPS to expedite the delivery. For further questions, please call (434) 975-8000
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Reason
The abx pentra reagent containers do not always sit properly into the reagent rack. in low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm.
Action
The firm initiated their recall by letter on 11/21/2017. The letter stated the following:
"A new production of reagent container compliant for each reference is under process and will be made available very soon. In the meantime and to allow a proper operating of the analyzer ABX PENTRA 400 / PENTRA C400, it Is necessary to push the reagent containers in the reagent racks until they touch the bottom of the rack.
Please share this information with your laboratory staff, and retain this notification as part of your Quality System documentation. It is mandatory for you to complete and return the enclosed response form within 10 days so we
may maintain our records."
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Reason
The abx pentra reagent containers do not always sit properly into the reagent rack. in low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm.
Action
The firm initiated their recall by letter on 11/21/2017. The letter stated the following:
"A new production of reagent container compliant for each reference is under process and will be made available very soon. In the meantime and to allow a proper operating of the analyzer ABX PENTRA 400 / PENTRA C400, it Is necessary to push the reagent containers in the reagent racks until they touch the bottom of the rack.
Please share this information with your laboratory staff, and retain this notification as part of your Quality System documentation. It is mandatory for you to complete and return the enclosed response form within 10 days so we
may maintain our records."
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Unpaired lots of au lyophilized chemistry calibrator level 1 and 2 have been distributed. calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. if lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results. qc failures could occur if incorrect pairs of calibrators are used.
Action
On August 28, 2017 a letter was sent to all the customers stating the following:
Attention Beckman Coulter Customer,
Beckman Coulter is initiating a field action for the product listed above. This letter contains important information that needs your immediate attention.
ISSUE:
¿ Unpaired lots of AU Lyophilized Chemistry Calibrator level 1 and 2 have been distributed.
¿ Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination.
¿ Paired calibrator lots are identified by the last two digits of the lot number.
Calibrator Level 1 REF DR0070-1, Lot 6101K51
Calibrator Level 2 REF DR0070-2, Lot 6102K61
Incorrect pair
Calibrator Level 1 REF DR0070-1, Lot 6101K61
Calibrator Level 2 REF DR0070-2, Lot 6102K61
Correct pair
IMPACT:
¿ If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results.
¿ QC failures could occur if incorrect pairs of calibrators are used.
Calibrator Level 1 REF DR0070-1, Lot 6101K51
Calibrator Level 2 REF DR0070-2, Lot 6102K61
Incorrect pair
¿ If the above incorrect pair is run with Level 1 lot 6101K51and Level 2 lot 6102K51 set points, erroneous results could be generated for the following assays:
o Bicarbonate : maximum 11% bias low
o Calcium Arsenazo : maximum 5% bias low
o Calcium oCPC : maximum 5% bias low
o Inorganic Phosphorous : 6.4% bias high
o Magnesium: 3.2% bias low
¿ If the above incorrect pair is run with Level 1 lot 6101K61 and Level 2 lot 6102K61 set points, erroneous results could be generated for the following assays:
o Bicarbonate : maximum 15.8% bias high
o Direct Bilirubin OSR6x181: 8.7% bias low
ACTION: ¿ Check the level 1 and level 2 calibrators to make sure you are using
correctly paired lots for calibration.
¿ Ensure correct set points are being used for the lot. Set points are in
the IFU for each lot and can be found in each kit, or on the Beckman
Coulter websites
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Issue with ecg out cables. when a philips monitor/defibrillator is receiving an ecg signal from an auxiliary bedside monitor via a sync cable or ecg out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (efts):
" on the heartstart mrx and heartstart xl, eft noise may be misinterpreted as an r-wave.
" on the heartstart xl+, eft noise can disable ecg monitoring and potentially interrupt demand mode pacing*.
*note: it is contrary to the xl+ instructions for use to perform demand mode pacing while using the ecg out cable or obtaining the ecg signal from a bedside monitor. the xl+ instructions for use includes the following warning: when pacing in demand mode, the ecg cable from the patient must be directly connected to the heartstart xl+. if the user follows this warning, this problem cannot occur on the xl+.
Action
Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent
Medical Device Correction notification/Field Safety Notice:
Customers should remove affected sync cables and ECG out cables from service and destroy them, documenting such action on the attached reply form, which should be returned to Philips. Customers should retain a copy of the reply form.
The customer should follow the Instructions for Use that describe the recommended approach for performing cardioversion with the XL+ and MRx monitor/defibrillators. The ECG trunk cable can be disconnected from the Philips bedside monitor and connected to the monitor/defibrillator before delivering therapy; this is the preferred source of an ECG waveform for synchronization.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Probe, radiofrequency lesion - Product Code GXI
Reason
After multiple reprocessing cycles, the epoxy resin which holds the tcn electrode in the hub can exhibit signs of damage. in some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device.
Action
The firm, Cosman Medical, sent an "Urgent Medical Device Correction" notice and Field Correction Reply Verification Tracking Form dated July 5, 2017 to their customers. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following:
1. Immediately discontinue use of devices that have already been used.
Used TCN Electrodes should be disposed of in accordance with your institutions infectious material/biohazard waste control procedures.
2. Unused/un-opened TCN Electrodes should be identified as single use only (for one patient). These devices are supplied as non-sterile which require cleaning and sterilization prior to use. These TCN Electrodes may be used once the cleaning and sterilization steps are completed.
After single use, the used TCN Electrode should be disposed of in accordance with your institutions infectious material/biohazard waste control procedures.
3. Complete and return the Field Correction Reply Verification Tracking Form.
via Email: Cosmanorders@bsci.com or via Fax to: 781-272-6563 - Identify your email with TCN Electrodes Action in the subject line.
Customers with questions may call 1-888-8COSMAN or email Cosmanorders@bsci.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Zimmer biomet is conducting a medical device recall for the explor 6x24mm implantable stem with screw due to a complaint alleging that the modular radial hd lock screw was not included in the package for the stem.
Action
Zimmer Biomet sent US Fiedl action notices 6/16/17 via email and fed Ex.
On 9/5/17, firm expanded their recall to include 1 lot and distributed Amended notices via email and FedEx
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Action
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Sleeve, limb, compressible - Product Code JOW
Reason
3040 compression sleeves being mislabeled as a 3010-pl compression sleeves.
Action
An Urgent Medical Device Recall letter, dated December 5, 2017, was distributed to customers. The letter described the affected product and stated the reason for the recall, as well as the risk to health. Customers were instructed to discontinue use of the affected device ,and complete and return the recall effectiveness check form. All affected product should be returned per the instructions provided and a credit will be issued.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a human error at a supplier, an unknown number of devices within one specific production lot of brainlab drapelink adapters (left/right) were not
manufactured according to defined specifications.
Action
Customers were notified, via email on approximately 11/16/2017. Instructions included to identify all affected devices on hand, cease use of the affected device, and a Brainlab Customer Support Representative will contact the customer to arrange a service visit to replace the item
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Catheter, thrombus retriever - Product Code NRY
Reason
Stryker neurovascular has become aware that at least 1 (one) trevo xp provue system was manufactured where the carton sleeve did not match the physical contents of the pack.
Action
The affected consignees will be notified via letter sent a courier beginning 11/28/17. A response form has been provided which customers have been asked to complete, and correct affected product is being requested.