Stryker Orthopaedics, Accolade Distal Centralizer 13 mm Medium; Catalog No.: 1059-4513. For use with Accolade hip prosth
FDA device recall Z-1594-2010 · posted 2010-05-12 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have been labeled as size 14 Large centraliizers.
- Action taken
- Notification letters and Product Accountability Forms have been sent to Stryker Orthopaedics Branch and Agencies via Fed Ex on March 31, 2010 with return receipt.. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons were sent notificatio letters and Product Recall Acknowledgment Forms on April 1, 2010. with return reciept.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 15
- Distribution
- Nationwide distribution.
- Date initiated
- 2010-03-31
- Date posted
- 2010-05-12
- Date terminated
- 2010-07-09
- 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 |
|---|---|---|
| DISTAL CENTRALIZER, EXETER II HIP SYSTEM (K974054) | Howmedica, Inc. | 1997-12-23 |