Recall Z-0477-03 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Inc.
Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 16, standard body. Cat. No. 7841-16-10.
| Date | Jan 28, 2003 (initiated Jan 7, 2003) |
| Status | Terminated |
| Reason | The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper. |
| Root cause | Other |
| Action | Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail. |
| Distribution | United States, Australia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922071 | ZIMMER ANATOMIC HIP SYSTEM Zimmer, Inc., Feb 22, 1994 |