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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer NexGen LPS Flex Gender

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  Class 2 Device Recall Zimmer NexGen LPS Flex Gender see related information
Date Initiated by Firm September 15, 2010
Date Posting Updated December 02, 2010
Recall Status1 Terminated 3 on July 27, 2011
Recall Number Z-0533-2011
Recall Event ID 57178
510(K)Number K960279  K060370  
Product Classification knee prosthesis femoral component - Product Code JWH
Product Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size G Left, sterile, REF 00-5764-017-51.
Code Information 61499865
Recalling Firm/
Manufacturer
Zimmer Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Cheryl Trease
574-267-6131
Manufacturer Reason
for Recall
These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all devices have nonconforming geometry.
FDA Determined
Cause 2
Process design
Action The firm sent URGENT DEVICE CORRECTION AND REMOVAL notices to distributors and sales staff, Risk Managers, and implanting surgeons dated 9/15/2010. Sales staff and risk managers were instructed to return any product on hand. Surgeons were informed of the issue but there was no action to be taken by surgeons.
Quantity in Commerce 158 all sizes of 5764
Distribution US, Germany, Spain, France, UK, Italy, Sweden, South Africa, Czech Republic, Bulgaria, Poland, Romania, and Austria.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ZIMMER, INC.
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