Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.
FDA device recall Z-0390-2010 · posted 2009-11-23 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JDG
- Quantity affected
- 7 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2009-09-04
- Date posted
- 2009-11-23
- Date terminated
- 2013-06-26
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIDENT LARGE DIAMETER HIP SYSTEM (K061434) | Howmedica Osteonics Corp. | 2006-08-22 |
| 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) (K022077) | Howmedica Osteonics Corp. | 2002-07-25 |
| LFIT V40 FEMORAL HEAD COMPONENTS (K010757) | Howmedica Osteonics Corp. | 2001-04-11 |
| HOWMEDICA OSTEONICS FEMORAL HEADS (K993601) | Howmedica Osteonics Corp. | 1999-11-16 |