Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325
FDA device recall Z-1241-2007 · posted 2007-09-21 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Loose fixation pegs: One lot of femoral components may have loose fixation pegs.
- Action taken
- Notification letters, dated 10/17/2006, were sent via Federal Express on 10/17/2006 to all consignees requesting return of product.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 3 total, 2 in USA
- Distribution
- Worldwide : One Hospital in Georgia (USA), Stryker Branch in Indiana and Stryker Branch in Sweden.
- Date initiated
- 2006-10-17
- Date posted
- 2007-09-21
- Date terminated
- 2009-07-07
- 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 |
|---|---|---|
| DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC (K920034) | Pfizer Hospital Products Group, Inc. | 1992-03-18 |