Recall Z-1685-2009 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France. Single use devices intended for cementless fixation within the prepared acetabulum. Intended for use with the mating Trident Polyethylen Cup Inserts.
| Date | Aug 13, 2009 (initiated May 29, 2007) |
| Status | Terminated |
| Reason | Stryker Orthopaedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301 |
| Root cause | Labeling mix-ups |
| Action | Stryker Orthopaedics issued an "Important Market Withdrawal" notice via Federal Express dated May 29, 2007. Consignees were asked to locate and return affected product and fax the attached Product Accountability Form to 1-201-831-6069. For further questions, contact Stryker Orthopaedics at 1-201-831-5825. |
| Quantity | 2 units |
| Distribution | Distributed to 2 Stryker branches. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013676 | TRIDENT HEMISPHERICAL ACETABULAR SHELLS Howmedica Osteonics Corp., Dec 5, 2001 |