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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Biomet

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 Class 2 Device Recall Zimmer Biometsee related information
Date Initiated by FirmMay 08, 2017
Date PostedMay 22, 2017
Recall Status1 Terminated 3 on December 01, 2017
Recall NumberZ-2198-2017
Recall Event ID 77223
Product Classification unknown device name - Product Code N/A
ProductReusable instruments in the Knee, Hip, Trauma, and Extremities segments.
Code Information All lots in distribution prior to 5/8/17
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		Durability characteristics of reusable instruments were not established
FDA Determined
Cause 2		Device Design
ActionOn 5/8/2017, URGENT MEDICAL DEVICE RECALL (CORRECTION) notifications were sent to the affected US sales representatives and distributors via e-mail. 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. Your Responsibilities: 1. Review this notification and ensure affected team members are aware of the contents. 2. Distributors return the Attachment 1 Acknowledgment Form to corporatequality.postmarket@zimmerbiomet.com (Return one form per territory. Sales representatives do not need to sign an acknowledgment form.) 3. Training will automatically be assigned to sales representatives and distributors, and a list of these trainees will be provided. Review the list of trainees to ensure that all applicable sales representatives are listed. If you have additional trainees to report, send a list that includes the trainees name, title, and email address to corporatequality.postmarket@zimmerbiomet.com. 4. Access the computer-based training. a. Log into Biomet University and navigate to your learning requirements. b. Complete the computer-based training module for the Reusable Instrument Lifespan Manual listed in your learning requirements. c. Complete the accompanying course assessment. 5. Access the RILM one of two ways: a. Via direct link http://www.zimmer.com/medical-professionals/support/disassembly-manual-reusable-instrument-lifespan-manual.html b. Via path Zimmer.comMedical ProfessionalsSupport Drop-DownDisassembly Manual/Reusable Instrument Lifespan Manual. 6. Immediately begin using the RILM to evaluate reusable instruments according to the training guidance. 7. If you have questions about the RILM, please contact Michael Aziz: Michael.Aziz@zimmerbiomet.com. International distributors will be notified via email. Further distribution of international notices will be sent through the local and
Quantity in CommerceGreater than 10,000,000 last 10 years
DistributionNationwide Worldwide
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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