Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Howmedic
FDA device recall Z-0072-2008 · posted 2007-10-25 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.
- Action taken
- Recall notification letters were sent out on August 30, 2007 with return receipt.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 142 units
- Distribution
- Product was distributed nationwide and one unit to Brazil.
- Date initiated
- 2007-08-30
- Date posted
- 2007-10-25
- Date terminated
- 2008-09-05
- 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 |