Recall Z-2139-2009 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 40 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
| Date | Sep 14, 2009 (initiated Jun 26, 2009) |
| Status | Terminated |
| Reason | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. |
| Root cause | Nonconforming Material/Component |
| Action | Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970. |
| Quantity | 51,113 total - all sizes. |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K873251 | OMNIFIT BONE SCREW Osteonics Corp., Sep 18, 1987 |