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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer NexGen LPS

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 Class 2 Recall
Zimmer NexGen LPS
see related information
Date Posted December 02, 2010
Recall Status1 Terminated on July 27, 2011
Recall Number Z-0532-2011
Recall Event ID 57178
Premarket Notification
510(K) Numbers
K060370  K960279 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size E Right, sterile, REF 00-5996-015-02.
Code Information 61494589
Recalling Firm/
Manufacturer
Zimmer Inc.
1800 W Center St
Warsaw, Indiana 46580-2304
Consumer Instructions No consumer action necessary
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
DESIGN: 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 192 all sizes of 5996.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ZIMMER, INC.
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