Recall Z-1817-2009 ยท HWA Impactor
Stryker Howmedica Osteonics Corp.
Lateral Decubitus Alignment Guide, Non Sterile; manual surgical instrument. The MIS Hip Acetabular instrument set includes the curved positioner/impactor, supine alignment guide, and decubitus alignment guide. Catalog No. 1440-1370 Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. Authorized Representative in Europe: Stryker France, Cedex France. The correct position of the cup r
| Date | Aug 27, 2009 (initiated Apr 27, 2006) |
| Status | Terminated |
| Reason | The Lateral Decubitus Alignment Guide either did not assemble to its mating part, the Curved Impaction Handle, or partially engages the handle, but does not fully lock. |
| Root cause | Nonconforming Material/Component |
| Action | Important Market Withdrawal Letters were sent to Stryker Branches on April 27, 2006 vis Federal Express. The letter asked consignees to examine their inventory and identify the product. They are to retrieve all affected product lots and return to their branch or agency warehouse for reconciliation. Also, they are to reconcile all product on the attached Product Accountability Form and fax a copy. Affected should be returned and their Stryker Orthopaedics Customer Service Rep should be contacted to re-order the product that is being returned as part of this recall. Questions should be refe |
| Quantity | 61 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.