Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-cons
FDA device recall Z-1381-2008 · posted 2008-07-16 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component.
- Action taken
- Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 7 units
- Distribution
- Worldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK.
- Date initiated
- 2005-02-08
- Date posted
- 2008-07-16
- Date terminated
- 2008-07-16
- 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 |
|---|---|---|
| OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM (K974556) | Osteonics Corp. | 1998-02-27 |