Recall Z-0315-2011 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Ortho Development Corporation
Distal Centralizer 10 mm
| Date | Nov 3, 2010 (initiated Jul 28, 2010) |
| Status | Terminated |
| Reason | The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper. |
| Root cause | Nonconforming Material/Component |
| Action | Ortho Development sent a Field Notification Memo dated July 28, 2010 to Japan Medical Dynamic Marketing instructing them to reconcile parts that may have been used and return unused parts to Ortho. Customers can contact Ortho Development at 1-801-619-3419. |
| Quantity | 39 units |
| Distribution | Worldwide Distribution: Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962448 | PRIMALOC CEMENTED HIP SYSTEM Ortho Development Corp., Sep 19, 1996 |