Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemented use only, tivanium TI-6AL-4V alloy/UHMWPE, sterile; Catalog no. 05-5998-038-02.
FDA Recall Z-0209-2007 · Posted 2006-11-22
Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2006-10-12
Date Terminated2007-12-10
Product Quantity18
Reason for Recall
The polyethylene tibial articular surface may not lock into some of the tibial plates.
Firm Action
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
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.