Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker Orthopaedics
FDA device recall Z-0059-06 · posted 2005-10-15 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.
- Action taken
- The recall notification was sent out via FedEx on 8/11/2005 with requested return receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 7 units
- Distribution
- The product was distributed to their sales representatives/sales agencies, hospitals, and international distribution. The product was shipped to Stryker Germany and Stryker France.
- Date initiated
- 2005-08-11
- Date posted
- 2005-10-15
- Date terminated
- 2007-08-15
- 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 POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM (K974556) | Osteonics Corp. | 1998-02-27 |