Recall Z-1476-06 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Inc.
Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, spout body, size D, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9990-20-46 (Cat. no. 00999002046).
| Date | Aug 31, 2006 (initiated Aug 2, 2006) |
| Status | Terminated |
| Reason | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
| Root cause | Other |
| Action | Consignees were notified via letter dated 8/2/06 to cease use of and to return the products. Zimmer distributors were to examine stock and return product on hand. |
| Quantity | 181 of all devices |
| Distribution | Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994286 | ZMR HIP SYSTEM-POROUS REVISION Zimmer, Inc., Mar 10, 2000 |