Ortho Development Corporation
Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in Japan only.)
| 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 | 14 |
| Distribution | TX and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.