Recall Z-1472-06 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Inc.
Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -extended neck offset, size 15, 160 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum, sterile; Cat. no. 00-7864-015-20 (00786401520).
| 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
| K051491 | TRABECULAR METAL PRIMARY HIP PROSTHESIS Zimmer, Inc., Jun 30, 2005 |