Recall Z-0209-2007 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Inc.
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.
| Date | Nov 22, 2006 (initiated Oct 12, 2006) |
| Status | Terminated |
| Reason | The polyethylene tibial articular surface may not lock into some of the tibial plates. |
| Root cause | Other |
| 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. |
| Quantity | 18 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963148 | NEXGEN COMPLETE KNEE SOLUTION Zimmer, Inc., Feb 13, 1997 |