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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Zimmer NexGen LPS 		see related information
Date Posted December 02, 2010
Recall Number Z-0528-2011
Product Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Left, sterile, REF 00-5996-017-01.
Code Information 61488063
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
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.
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 products
Distribution US, Germany, Spain, France, UK, Italy, Sweden, South Africa, Czech Republic, Bulgaria, Poland, Romania, and Austria.
 
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