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Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemente

FDA device recall Z-0209-2007 · posted 2006-11-22 · Terminated

Recall details

Recalling firm
Zimmer Inc.
Reason for recall
The polyethylene tibial articular surface may not lock into some of the tibial plates.
Action taken
Consignees were notified by a letter dated 10/12/06 and sent to operating room supervisors and Zimmer distributors to cease using the product and to return it to the firm.
Root cause
Other
Status
Terminated
Product code
JWH
Quantity affected
18
Distribution
Nationwide.
Date initiated
2006-10-12
Date posted
2006-11-22
Date terminated
2007-12-10
Location
Warsaw, IN

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Related 510(k) clearances

RecordFirmDate
NEXGEN COMPLETE KNEE SOLUTION (K963148)Zimmer, Inc.1997-02-13