—#48971

Product

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 product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K963148
Affected lot / code info: Lot 60472442; exp. May 2011.

Why it was recalled

The polyethylene tibial articular surface may not lock into some of the tibial plates.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-10-12
Posted by FDA: 2006-11-22
Terminated: 2007-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48971. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.