Recall Z-1261-2007 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Osteonics Corp., 325 Corporate DriveMahway, NJ 07430
| Date | Sep 26, 2007 (initiated Mar 13, 2006) |
| Status | Terminated |
| Reason | Dimensional anomaly |
| Root cause | Other |
| Action | Recall Notification letters were sent on March 13, 2006 to all hospitals, branches/agencies via Federal Express. |
| Quantity | 1,220 units |
| Distribution | Worldwide -USA, Romania, Chile and 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 |