Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use
FDA device recall Z-2079-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.
- Action taken
- The International Stryker Distributor was notified via an advisory notice with return receipt on March 18, 2005
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1 unit
- Distribution
- The one unit was distributed to an International Stryker branch.
- Date initiated
- 2005-03-17
- Date posted
- 2008-09-16
- Date terminated
- 2008-09-24
- 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 |
|---|---|---|
| OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM (K962152) | Osteonics Corp. | 1996-08-14 |