Recall Z-0126-06 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Plus Orthopedics USA
TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
| Date | Nov 3, 2005 (initiated Feb 22, 2005) |
| Status | Terminated |
| Reason | Labeling discrepancy. |
| Root cause | Other |
| Action | Firm retrieved the unit from the consignee and returned it to the manufacturer. Firm indicates that Operations contacted the agent site and requested the return. |
| Quantity | 1 unit |
| Distribution | NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000666 | TC-PLUS SOLUTION KNEE Plus Orthopedics, Oct 13, 2000 |