Recall Z-1468-06 ยท LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Zimmer Inc.
Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-14-04 (00786101404).
| 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
| K961378 | DELTA HIP PROSTHESIS Zimmer, Inc., Oct 8, 1996 |