Recall Z-0108-06 ยท MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Stryker Howmedica Osteonics Corp.
Reliance PF Femoral Stem
| Date | Nov 1, 2005 (initiated Aug 24, 2005) |
| Status | Terminated |
| Reason | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. |
| Root cause | Other |
| Action | A urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated. |
| Quantity | 8487 units |
| Distribution | nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970200 | RELIANCE PF FEMORAL STEMS Howmedica Corp., Apr 9, 1997 |