Recall Z-0391-2010 ยท JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.
| Date | Nov 23, 2009 (initiated Sep 4, 2009) |
| Status | Terminated |
| Reason | Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head. |
| Root cause | Process control |
| Action | Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009. |
| Quantity | 10 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010757 | LFIT V40 FEMORAL HEAD COMPONENTS Howmedica Osteonics Corp., Apr 11, 2001 |
| K022077 | 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) Howmedica Osteonics Corp., Jul 25, 2002 |
| K061434 | TRIDENT LARGE DIAMETER HIP SYSTEM Howmedica Osteonics Corp., Aug 22, 2006 |
| K993601 | HOWMEDICA OSTEONICS FEMORAL HEADS Howmedica Osteonics Corp., Nov 16, 1999 |