Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stry
FDA device recall Z-0795-2010 · posted 2010-02-19 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT.
- Action taken
- Stryker Orthopaedics issued an "Important Product Removal" letter via Federal Express dated July 30, 2007 to all direct accounts. Users were asked to identify and return all affected product to the firm. For further information, contact Stryker Orthopaedics at (201) 831-5825.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 7
- Distribution
- Worldwide Distribution -- United States and France.
- Date initiated
- 2007-07-30
- Date posted
- 2010-02-19
- Date terminated
- 2010-02-19
- 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 |