Citation AT Femoral Stem
FDA device recall Z-0109-06 · posted 2005-11-01 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAY
- Quantity affected
- 207 units
- Distribution
- nationwide
- Date initiated
- 2005-08-24
- Date posted
- 2005-11-01
- Date terminated
- 2006-04-05
- 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 |
|---|---|---|
| HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT (K955871) | Howmedica Corp. | 1996-03-22 |