Recall Z-1186-03 ยท MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Wright Medical Technology Inc
Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system.
| Date | Aug 28, 2003 (initiated Aug 18, 2003) |
| Status | Terminated |
| Reason | Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation. |
| Root cause | Other |
| Action | Distributors returned thier stock after May 8, 2003 |
| Quantity | 133 units |
| Distribution | nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.