Recall Z-0072-2008 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Howmedica Osteonics Corp. 325 Corporate Drive; Mahwah, NJ 07430; A subsidiary of Stryker Corp. Sterile, Made in USA.
| Date | Oct 25, 2007 (initiated Aug 30, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | Recall notification letters were sent out on August 30, 2007 with return receipt. |
| Quantity | 142 units |
| Distribution | Product was distributed nationwide and one unit to Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983382 | OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM Osteonics Corp., Dec 11, 1998 |