Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Ma
FDA device recall Z-1141-2010 · posted 2010-03-16 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.
- Action taken
- Stryker Important Product Removal Letters were sent via Federal Express on 8/20/2007.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 4 units
- Distribution
- Product went to 2 US Stryker branches.
- Date initiated
- 2007-08-20
- Date posted
- 2010-03-16
- Date terminated
- 2010-03-16
- 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 |
|---|---|---|
| SCORPIO NRG KNEE SYSTEM (K030978) | Howmedica Osteonics Corp. | 2003-11-20 |