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.
As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
Action
Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to
1.Review the notification and ensure that relevant personnel are aware of the contents.
2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet 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.
As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
Action
Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to
1.Review the notification and ensure that relevant personnel are aware of the contents.
2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet 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.
As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
Action
Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to
1.Review the notification and ensure that relevant personnel are aware of the contents.
2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet 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.
As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
Action
Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to
1.Review the notification and ensure that relevant personnel are aware of the contents.
2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet 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.
Extra notes in the data
Kit, i.V. Start - Product Code LRS
Reason
Compromised sterility due to breach of barrier.
Action
Covidien initiated recall by letter on March 4, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878
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.
As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
Action
Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to
1.Review the notification and ensure that relevant personnel are aware of the contents.
2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet 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.
As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
Action
Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to
1.Review the notification and ensure that relevant personnel are aware of the contents.
2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet 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.
As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
Action
Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to
1.Review the notification and ensure that relevant personnel are aware of the contents.
2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet 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.
The products have been identified to contain an incorrect size diaphragm.
Action
Cooper Surgical sent an "Urgent - Medical Device Recall" letter dated February 16, 2016, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer.
Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt form for replacement.
For further questions, please call (203) 601-9818.
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, nuclear magnetic resonance imaging - Product Code LNH
Reason
Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the qbc. the combined use of the sense coil, high sar level scanning and placement of the cables contrary to instructions for use can lead to patient burns.
Action
On 6/18/2015, the Field Safety Notice / Medical Device Correction Notice was sent to customers via certified mailing. The letter explains the issue and provides user instructions. A sleeve is being developed that will be applied to the cable on the Sense Body Coil 1.5T and provide consistent spacing between the cable and the patient, thereby reducing the chance of RF interaction and heating. This sleeve will be distributed as part of a Field Change Order with reference FCO781 00437 for Sense Body Coils in the installed base and will be installed by the Philips Field Service Engineers.
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.
Medtronic navigation is recalling the biotex adapter kit because it was commercially distributed by biotex without a cleared premarket [510(k)] from fda.
Action
The firm, Medtronic, sent an "URGENT Medical Device Recall" letter dated 2/2016 to its consignees. The letter described the product, problem and actions to be taken. The identified consignees will be visited by the assigned Medtronic field representative to explain the need for the field action. The consignees are instructed to locate and remove/secure the kit from use. The Medtronic field representative will assist the consignee with identifying and removing the kit, and complete a Customer Visit record for each consignee they are assigned/visit to document the results of their visit. The consignee is instructed to sign the customer visit form presented by the representative. A copy of this record and a letter explaining the FCA will be left with the consignee.
Please contact Medtronic Technical Services at 1-800-595-9709 if you have any questions regarding the subject action or the content of the letter.
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, corneal, refractive - Product Code LQE
Reason
Acufocus is recalling kamra aci 7000 corneal inlays due to concerns with the labeled shelf life.
Action
The firm, AcuFocus, sent an "URGENT FIELD SAFETY NOTICE" letter dated 2/11/16 to all their customers to inform them that AcuFocus is recalling 2 lots of KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. The described the product, problem and the actions to be taken. Customers are instructed to report any abnormal appearance of the implanted KAMRA inlay to AcuFocus, inc; stop using and remove from your inventory all affected lots; complete and return the attached Customer Recall Response Form via email: customerservice@acufocus.com, Fax: +1 (949) 585-9545 Attn: Recall Coordinator, or mail to: AcuFocus Inc., Attn: Recall Coordinator, 32 Discovery, Suite 200, Irvine CA 92618, within 3 business days even if you have no inventory affected by this recall; and provide the attached Customer Field Safety Notice and Customer Recall Response Form to your customers who have or may have received product from the affected two lots.
Customers with product complaint events are instructed to report regarding KAMRA inlays involved in this recall event, and to inform AcuFocus, Inc. by calling +1 (949) 585-9511 ext 608. Customers with any questions related to the return process, are instructed to contact an AcuFocus Customer Service Representative at +1 (949) 585-9511 ext 608.
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.
Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.
Action
On February 5, 2016 Arthrex sent Urgent Medical Device Voluntary Recall letters to their distributors and Surgeons/Medical Facilities reporting the removal. The letter identified the reason for the recall, the potential patient impact, and actions to be taken. Users were to discontinue use of the identified affected devices and follow the instructions provided to return the affected devices that have not been implanted. To return the devices, contact Arthrex at 1-866-267-9138 or by fax at 1-239-591-6943 or via e-mail at Complaints@Arthrex.com. Customers must complete and return the Acknowledgement and Receipt.
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
Horiba instruments, inc. is recalling abx pentra 400( version 5.0.8 or lower) and pentra c400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.
Action
HORIBA Medical sent an "Urgent Safety Notice" dated February 19, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
A new software version to solve the issue is currently under development; however the firm requests customers use the provided procedure until the new software version is installed on the system, or be extremely vigilant with results of one of the alarms mentioned appears on the system. The letter instructs customers to share the information with laboratory staff and retain the notification as part of laboratory documentation. The letter states it is mandatory for customers to complete and return the enclosed response form within 10 days, in order to verify understanding of it.
Any questions or concerns contact the local Horiba Medical representative.
For further questions, please call (949) 250-4811.
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
duodenoscope and accessories, flexible/rigid - Product Code FDT
Reason
Pentax medical learned of reports of carbapenem-resistant enterobacteriaceae (cre) infection at a medical facility.
Action
Pentax Inc. issued an "Urgent Field Correction" Letter dated February 19, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letter provides information regarding the updated Reprocessing instruction for use along with some main changes in the Operation IFU. Instructions are also provided regarding prior versions of the Reprocessing and Operation Instructions for Use. A web posting went live on 2/19/2016.
For further questions, please call:
Tel:800-431-5880 ext. 2064 (8:30AM- 5:00 PM, Monday-Friday, EST)
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
Horiba instruments, inc. is recalling abx pentra 400( version 5.0.8 or lower) and pentra c400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.
Action
HORIBA Medical sent an "Urgent Safety Notice" dated February 19, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
A new software version to solve the issue is currently under development; however the firm requests customers use the provided procedure until the new software version is installed on the system, or be extremely vigilant with results of one of the alarms mentioned appears on the system. The letter instructs customers to share the information with laboratory staff and retain the notification as part of laboratory documentation. The letter states it is mandatory for customers to complete and return the enclosed response form within 10 days, in order to verify understanding of it.
Any questions or concerns contact the local Horiba Medical representative.
For further questions, please call (949) 250-4811.
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
Plasma, coagulation control - Product Code GGN
Reason
Customer complaints about failed target ranges for alpha angle. firm has not completed the capa identifying the root cause. projected completion of the capa by the firm is july 2016.
Action
An Urgent Important Customer Information notice was sent to accounts on 2/17/2016. The notice requested that they discontinue use of the product and to contact them for a replacement. The letter also included a response form to be returned.
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 initiating a medical device correction notice to provide updated cleaning and disinfecting instructions for use of the instinct¿ java¿ system (ifu reference: 046wan0000t) and universal clamp¿ system (ifu reference: sna027-n-90001).
Action
Consignees were sent on 2-12-2016 a Zimmer Biomet "Urgent Medical Device Correction Notice" letter dated February 12, 2016. The letter was either addressed to Hospital Representative or to Distributors, Sales Representatives, and Distribution Operations Managers. The letters described the problem and the product involved in the recall. Advised consignees to immediately utilize the updated and attached Instructions For Use. Requested consignees to complete the "Acknowledgement of Field Notification" form. For questions contact Customer Service at 1-866-774-6368 or e-mail corporatequality.postmarket@zimmerbiomet.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 initiating a medical device correction notice to provide updated cleaning and disinfecting instructions for use of the instinct¿ java¿ system (ifu reference: 046wan0000t) and universal clamp¿ system (ifu reference: sna027-n-90001).
Action
Consignees were sent on 2-12-2016 a Zimmer Biomet "Urgent Medical Device Correction Notice" letter dated February 12, 2016. The letter was either addressed to Hospital Representative or to Distributors, Sales Representatives, and Distribution Operations Managers. The letters described the problem and the product involved in the recall. Advised consignees to immediately utilize the updated and attached Instructions For Use. Requested consignees to complete the "Acknowledgement of Field Notification" form. For questions contact Customer Service at 1-866-774-6368 or e-mail corporatequality.postmarket@zimmerbiomet.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.
Extra notes in the data
Cabinet x-ray, industrial - Product Code RCE
Reason
Ge inspection technologies, lp ("ge") has discovered that certain of its cabinet x-ray systems may not fully comply with the food and drug administration's (fda) cabinet x¿ ray system performance standards, 21 c.F.R. ¿ 1020.40(c)(1)(i).
Action
GE Inspection Technologies Planned Action to bring into Compliance:
1. GE Inspection Technologies will use their updated adhesive procedure to install new brackets to the bottom left and right lead strips in the control door. The new procedure and brackets were developed in November 2013.
2. A second notification of customers with affected systems will be sent within
5 days of approval of this CAP. This notification will describe the repair above and propose that a GE technician visit each site and install the described repair.
3. Repairs will be completed within 120 days after approval of this CAP and will be made free of charge. For further questions, please call (717) 447-1278.
;
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
Detector and alarm, arrhythmia - Product Code DSI
Reason
The firm received a complaint of the battery exploding while recharging.
Action
On 2/26/2016 the firm sent "Urgent: TeleSentry Battery Recall" notification letters to their customers. The letter identified the affected device and the reason for the recall. Customers were asked to immediately examine their inventory and quarantine the affected device. If the product had been further distributed, then a copy of the letter should be provided to those customers. Customers are to follow the steps provided for returning the affected device, including contacting ScottCare Service at 1-800-243-9412. In addition, the attached response form should be completed and returned. Questions should be directed to ScottCare Customer Service at 1-800-243-9412.
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
Gas-machine, anesthesia - Product Code BSZ
Reason
Ge healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all aisys cs2 and upgraded aisys anesthesia devices.
Action
Consignees were sent on 2/17/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 34075 dated February 17, 2016.The letter was addressed to Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions, Affected Product Details, 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.
Potential for obtaining a false positive result due to the possibility of endotoxin presence.
Action
QIAGEN sent an "Urgent - Notification of Market Withdrawal" dated February 2, 2016, to all affected customers. The letter identify the product the problem and the action needed to be taken by the customer.
Immediately discontinue use of this lot and discard any remaining inventory. Please acknowledge receipt of this notification and actions taken by completing the information on the next page, and return to: TechService-NA@qiagen.com or fax +1-661-775-7479.
QIAGEN apologizes for any inconvenience this market withdrawal has caused, and continues to take every effort possible to ensure the highest quality of product is always available to our valued customers around the globe. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative should you have any questions or concerns.
For further questions, please call ( 240) 686-7500.
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
Orthosis, limb brace - Product Code IQI
Reason
Ossur americas is recalling , knee shield / patella cup, knee undersleeve gray, necloc extrication collar, rebound cartilage, rebound cartilage custom, rebound air walker, rebound diabetic walker, back support suspenders clip on black, back support suspenders sew on black, extreme custom, unloader custom xt, unloader custom lite, unloader custom, and papoose infant spine immobilizers because the p.
Action
The firm sent out customer notification letters on 02/26/16.
The notification letter instructed customers to include the latex caution notice in any existing inventory of affected products. The latex caution notice can be retrieved at the conclusion of the response survey or by going directly to
safetyalerts.ossur.com. Should customers require ¿ssur to provide pre-printed notices for existing inventory, contact ¿ssur customer service.
For the ¿ssur Miami J¿ Cervical Collars with lot numbers before MX150727 customers are instructed to remove and discard the assist strap, which contains natural rubber latex, located in the patient pack.
Recipients of the notice with should take the following actions:
1. Pass the notice to those who need to be aware within the organization or to any organization where the affected devices have been transferred.
2. Maintain awareness on this notification for an appropriate period.
3. If have further distributed the products, identify customers and notify them at once of the product alert. It is recommended to include a copy of the alert notification letter.
4. If any of your customers are currently wearing a product, check for any skin irritations or other reactions consistent with natural rubber latex allergies.
5. To verify have received the notification, visit safetyalerts.ossur.com to complete the Response Survey.
If any questions, contact ¿ssur Customer Service at (800) 233-6263.
The notification letter for the Papoose Infant Spine Immobilizer contained the following additional actions/instructions:
Examine inventory, quarantine products subject to the recall and contact customer service for a return authorization to return the product to ¿ssur.
If any of customers are currently wearing a product, it is recommended replacing the unit with one shipped after the transition lot number MX150727. Check for any skin irritations or other reactions consistent with natural rubber latex allergies.
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
Joint, knee, external brace - Product Code ITQ
Reason
Ossur americas is recalling , knee shield / patella cup, knee undersleeve gray, necloc extrication collar, rebound cartilage, rebound cartilage custom, rebound air walker, rebound diabetic walker, back support suspenders clip on black, back support suspenders sew on black, extreme custom, unloader custom xt, unloader custom lite, unloader custom, and papoose infant spine immobilizers because the p.
Action
The firm sent out customer notification letters on 02/26/16.
The notification letter instructed customers to include the latex caution notice in any existing inventory of affected products. The latex caution notice can be retrieved at the conclusion of the response survey or by going directly to
safetyalerts.ossur.com. Should customers require ¿ssur to provide pre-printed notices for existing inventory, contact ¿ssur customer service.
For the ¿ssur Miami J¿ Cervical Collars with lot numbers before MX150727 customers are instructed to remove and discard the assist strap, which contains natural rubber latex, located in the patient pack.
Recipients of the notice with should take the following actions:
1. Pass the notice to those who need to be aware within the organization or to any organization where the affected devices have been transferred.
2. Maintain awareness on this notification for an appropriate period.
3. If have further distributed the products, identify customers and notify them at once of the product alert. It is recommended to include a copy of the alert notification letter.
4. If any of your customers are currently wearing a product, check for any skin irritations or other reactions consistent with natural rubber latex allergies.
5. To verify have received the notification, visit safetyalerts.ossur.com to complete the Response Survey.
If any questions, contact ¿ssur Customer Service at (800) 233-6263.
The notification letter for the Papoose Infant Spine Immobilizer contained the following additional actions/instructions:
Examine inventory, quarantine products subject to the recall and contact customer service for a return authorization to return the product to ¿ssur.
If any of customers are currently wearing a product, it is recommended replacing the unit with one shipped after the transition lot number MX150727. Check for any skin irritations or other reactions consistent with natural rubber latex allergies.