Recall Z-0170-04 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Plus Orthopedics
TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
| Date | Nov 27, 2003 (initiated Sep 9, 2002) |
| Status | Terminated |
| Reason | Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted. |
| Root cause | Other |
| Action | Certified letters were sent out to the 2 providers that had implanted the device. The remaining inventory was exported back to the manufacturer. |
| Quantity | 5 |
| Distribution | TX, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.