Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Osteonics Corp., 325 Cor
FDA device recall Z-1261-2007 · posted 2007-09-26 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Dimensional anomaly
- Action taken
- Recall Notification letters were sent on March 13, 2006 to all hospitals, branches/agencies via Federal Express.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 1,220 units
- Distribution
- Worldwide -USA, Romania, Chile and Brazil.
- Date initiated
- 2006-03-13
- Date posted
- 2007-09-26
- Date terminated
- 2008-01-18
- 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 HA GENERATION II ACETABULAR COMPONENT SYSTEM (K983382) | Osteonics Corp. | 1998-12-11 |