Ortho Development Corporation
Hip Prosthesis as a component of Primaloc Cemented Hip System.
| Date | Feb 25, 2003 (initiated Dec 26, 2002) |
| Status | Terminated |
| Reason | Cleaning agent residue from packaging material was adhering to implantable hip stems. |
| Root cause | Other |
| Action | Consignees were notified on 12/26/2002 via telephone and e-mail. |
| Quantity | 41 |
| Distribution | TX and 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 |