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.
Ams custom kits containing medtronic covidien curity eye pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
Action
AMS sent an Urgent Medical Device Recall letter dated March 16, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit.
Customers should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to vdavis@alignedmedicalsolutions.com.
Customers can call Aligned Medical Solutions at 321-527-7714.
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.
Ams custom kits containing medtronic covidien curity eye pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
Action
AMS sent an Urgent Medical Device Recall letter dated March 16, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit.
Customers should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to vdavis@alignedmedicalsolutions.com.
Customers can call Aligned Medical Solutions at 321-527-7714.
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.
Ams custom kits containing medtronic covidien curity eye pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
Action
AMS sent an Urgent Medical Device Recall letter dated March 16, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit.
Customers should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to vdavis@alignedmedicalsolutions.com.
Customers can call Aligned Medical Solutions at 321-527-7714.
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.
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.
Keystone Dental initiated a market removal communication by telephone to customers on 3/9/2017. Customer Relations Fax Back Forms were completed to document these calls. In addition, a letter was sent via Federal Express/or hand delivered to all distributors and customers on 3/13/2017. Product returns requested and if implanted to implement healing and prosthetic protocol. Toll Free: 866-902-9272
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.
Cardiovascular systems, inc. is recalling one lot of viperwire advance with flextip, model vpr-gw-ft18 because it may contain a 0.014" viperwire advance flextip product instead of the 0.018" viperwire advance with flextip.
Action
Customers were sent an Urgent Medical Device Recall letter beginning March 03, 2017. The letter identified affected product, reason for recall, and asked for affected devices to be removed from use and return to CSI. Questions can be directed to CSI Customer Service at 877-274-0901, or your CSI Sales Representative.
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.
Ge healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where dicom worklist search response time is slow. this issue is limited to certain vivid ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. if not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. this issue could lead to misdiagnosis. there have been no injuries reported because of this issue.
Action
Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 76164,76168 dated March 10, 2017. The letter was addressed to Hospital Administrators / Risk Manager, Biomedical Engineering, & Managers of Radiology / Managers of Cardiology.
The letter described the safety Issue, Safety Instructions, Affected Product Detail, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
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
System, x-ray, mobile - Product Code IZL
Reason
The dx-d100 user manual already contained information about to move a dx-d100 mobile unit manually by using an allen wrench, but did not indicate where the allen wrench should be stored.
Action
AGFA Healthcare sent an On January 20,2016, an 'URGENT FIELD SAFETY NOTICE" dated January 20, 2016, to all affected customers by email or sent via FedEx to the US and Canadian consignees. The notice included an acknowledgment form to be sent back. The letter described background information and actions. Customers with questions were instructed to call 1-877-777-2432 and reference PR1405160001-VR0000288.
For questions regarding this recall call 864-421-1984.
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
Ventricular (assisst) bypass - Product Code DSQ
Reason
In april 2015, heartware, now a part of medtronic, notified users of a safety issue related to the hvad pump driveline splice kit. medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.
Action
HeartWare, now a part of Medtronic sent an Urgent Medical Device Recall letter on April 2015 and a follow-up letter on March 2017, to customers via overnight mail and/or email.. The letters identified the affected product, problem and actions to be taken. Customers were instructed to review the recall notice, forward the notice to individuals within their organization who need to be aware of the notice, complete, sign, and return the Acknowledgement Form . For questions contact your local HeartWare representative.
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.
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Action
On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Distributors, Sales Representatives, and Distributor Operation Managers
Your Responsibilities:
1. Review this notification and ensure affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet within 2 weeks.
a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Specify RECALL as the RGA type.
b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 with your shipment for immediate processing.
d. Clearly mark RECALL on the outside of return boxes.
5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional
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.
During patient interventions with the urology table the radiation is activated with a footswitch connected to the table. this footswitch is actively involved in the safety circuit of the urological table. only if footswitch + exposure + first primary barrier are closed the signal will be transmitted to the generator for activating x-ray. during intended use only with this footswitch x-ray should be activated.
Action
Pausch Medical will bring defect into compliance :
The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 10 units will consist of the following:
1. You will contact customers and initiate the hardware upgrade to correct the noncompliance.
2. You will install the hardware upgrade and perform testing to ensure this update was effective.
3. Your customer notification will include a statement that you will without charge, bring the product into compliance.
CDRH approves the CAP subject to the following conditions:
1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification.
2. You will send a list of the product locations and associated telephone number to the FDA district office.
3. You will implement this CAP by July 1, 2017.
You may proceed or continue with implementation of the CAP (subject to the conditions noted above).
All actions to install this retrofit kit 01164901 have been executed until Mar 13,2017. The additional retrofit kit 01164901 was extended to additional batches of the same Uroview FD device.
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
Implant, endosseous, root-form - Product Code DZE
Reason
A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier.
Action
On March 13 Zimmer Biomet contacted their international consignee and asked them to:
1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship within your territory along with a completed Attachment 1 Inventory Return Certification Form to Biomet 3i.
a. For each return, send a copy of Attachment 1 to postmarket@zimmerbiomet.com.
b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Mark the outside of the returns box(es) clearly with RECALL.
5. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility.
If after reviewing this notice you have further questions or concerns please contact us by email at postmarket@zimmerbiomet.com.
1-800-342-5454
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
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. if this occurs the liquid may drip onto electrical components in the r cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
Action
Consignees were notified of the recall via letter sent on 3/22/2017. The letter explains the issue, actions that should be taken by the customer, and actions to be taken by Philips.
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
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. if this occurs the liquid may drip onto electrical components in the r cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
Action
Consignees were notified of the recall via letter sent on 3/22/2017. The letter explains the issue, actions that should be taken by the customer, and actions to be taken by Philips.
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
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. if this occurs the liquid may drip onto electrical components in the r cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
Action
Consignees were notified of the recall via letter sent on 3/22/2017. The letter explains the issue, actions that should be taken by the customer, and actions to be taken by Philips.
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.
Ge healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where dicom worklist search response time is slow. this issue is limited to certain vivid ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. if not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. this issue could lead to misdiagnosis. there have been no injuries reported because of this issue.
Action
Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 76164,76168 dated March 10, 2017. The letter was addressed to Hospital Administrators / Risk Manager, Biomedical Engineering, & Managers of Radiology / Managers of Cardiology.
The letter described the safety Issue, Safety Instructions, Affected Product Detail, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
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 sent an Urgent Medical Device Recall Correction letter on February 27, 2017,to all affected customers informing them of the following:
Description of the issue:
A robot arm file parameter linked to arm calibration was modified by the robot arm supplier without notification to MEDTECH.
As a result, once the robot arm is on trajectory, an error leading to a device reboot may decrease the devices applicative accuracy, one of the essential performance requirements, to a level above the specification. This may happen after a shutdown of the device, (voluntary or due to an error), without a return of the robot arm position to a Parking position.
In the worst case scenario, this may cause an incorrect positioning of the instruments by the ROSA devices. If this is not detected by the user this could ultimately lead to ineffective treatment, serious injury or even death of the patient.
MEDTECH did not record, in normal conditions of use, any customer reports linked to this issue.
Required actions by users:
Pending the implementation of a permanent correction, MEDTECH is recommending the following actions to all users of the ROSA device:
1- After a shutdown of the device, (voluntary or due to an error), without a return of the robot arm in Parking position, ROSA device must be switched off with the I/O switch button on the device rear panel.
2- Restart the device after 10 seconds, and after full extinction of emergency button light. If the Reset button at the device rear panel is red, restart the ROSA PC by pushing the Reset button.
3- If robot position is NOT ¿ Home ¿, load patient folder and main software interface will appear on the screen.
a. Go to the Guidance menu, select trajectories and follow instructions.
b. Click on Start button.
c. Start recovery procedure and follow all instructions displayed on the screen until robot arm position is Home .
d. Close the patient folder
e. Click on Exit and follow all ins
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 sent an Urgent Medical Device Recall Correction letter on February 27, 2017,to all affected customers informing them of the following:
Description of the issue:
A robot arm file parameter linked to arm calibration was modified by the robot arm supplier without notification to MEDTECH.
As a result, once the robot arm is on trajectory, an error leading to a device reboot may decrease the devices applicative accuracy, one of the essential performance requirements, to a level above the specification. This may happen after a shutdown of the device, (voluntary or due to an error), without a return of the robot arm position to a Parking position.
In the worst case scenario, this may cause an incorrect positioning of the instruments by the ROSA devices. If this is not detected by the user this could ultimately lead to ineffective treatment, serious injury or even death of the patient.
MEDTECH did not record, in normal conditions of use, any customer reports linked to this issue.
Required actions by users:
Pending the implementation of a permanent correction, MEDTECH is recommending the following actions to all users of the ROSA device:
1- After a shutdown of the device, (voluntary or due to an error), without a return of the robot arm in Parking position, ROSA device must be switched off with the I/O switch button on the device rear panel.
2- Restart the device after 10 seconds, and after full extinction of emergency button light. If the Reset button at the device rear panel is red, restart the ROSA PC by pushing the Reset button.
3- If robot position is NOT ¿ Home ¿, load patient folder and main software interface will appear on the screen.
a. Go to the Guidance menu, select trajectories and follow instructions.
b. Click on Start button.
c. Start recovery procedure and follow all instructions displayed on the screen until robot arm position is Home .
d. Close the patient folder
e. Click on Exit and follow all ins
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.
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Action
On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Distributors, Sales Representatives, and Distributor Operation Managers
Your Responsibilities:
1. Review this notification and ensure affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet within 2 weeks.
a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Specify RECALL as the RGA type.
b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 with your shipment for immediate processing.
d. Clearly mark RECALL on the outside of return boxes.
5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional
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, percutaneous - Product Code DQY
Reason
Reflow medical is recalling the wingman 35 crossing catheter because it may be prone to tip detachment.
Action
An Urgent Medical Device Recall letter was issued 3/22/17 for the Wingman 35 Crossing Catheter. The recall was issued due to a risk of catheter tip detachment which could cause injury to vasculature and thromboembolic events. Customers are asked to complete the Response Form and reply via email (quality@reflowmedical.com) or fax number (760.290.3216), even if they have no product to return.
On 4/20/17, an Urgent Medical Device recall letter was sent to expand the recall to include all Wingman 35 Crossing Catheter lengths and lots manufactured since March, 2015.
On 5/3/17, ReFlow Medical issue a press release to a news wire through PR.com to inform their customers that FDA is classifying this as a Class 1 recall. The press states that the Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. ReFlow has received 2 complaints of catheter-tip splitting and/or separation. A total of 2327 Wingman catheters are in distribution. Consumers with questions may contact ReFlow Medical Customer Relations at 1-949-481-0399, Monday through Friday, between 8:00 a.m. and 4:30 p.m. Pacific time or by email at info@reflowmedical.com.
On 5/9/17, ReFlow Medical sent an updated press release to the newswire to correct the distribution dates from January 2015 and March 2016 to March 2015 and March 2017.
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.
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Action
On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Distributors, Sales Representatives, and Distributor Operation Managers
Your Responsibilities:
1. Review this notification and ensure affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet within 2 weeks.
a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Specify RECALL as the RGA type.
b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 with your shipment for immediate processing.
d. Clearly mark RECALL on the outside of return boxes.
5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional
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
unknown device name - Product Code N/A
Reason
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Action
On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Distributors, Sales Representatives, and Distributor Operation Managers
Your Responsibilities:
1. Review this notification and ensure affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet within 2 weeks.
a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Specify RECALL as the RGA type.
b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 with your shipment for immediate processing.
d. Clearly mark RECALL on the outside of return boxes.
5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional
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
Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
Reason
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Action
On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Distributors, Sales Representatives, and Distributor Operation Managers
Your Responsibilities:
1. Review this notification and ensure affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet within 2 weeks.
a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Specify RECALL as the RGA type.
b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 with your shipment for immediate processing.
d. Clearly mark RECALL on the outside of return boxes.
5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional
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, surgical - Product Code GFG
Reason
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming.
Action
Smith &n; Nephew sent an Urgent Medical Device Recall Notice dated March 15, 2017, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return product and to follow instructions on the attached Response Form. Customers with questions were instructed to email FieldActions@smith-nephew.com.
For questions regarding this recall call 508-261-3600.
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, surgical - Product Code GFG
Reason
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming.
Action
Smith &n; Nephew sent an Urgent Medical Device Recall Notice dated March 15, 2017, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return product and to follow instructions on the attached Response Form. Customers with questions were instructed to email FieldActions@smith-nephew.com.
For questions regarding this recall call 508-261-3600.