Recall Z-0018-06 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Plus Orthopedics USA
TC-PLUS Tibial Insert UC 6; 13mm, Model 25438
| Date | Oct 7, 2005 (initiated Aug 3, 2005) |
| Status | Terminated |
| Reason | Did not meet specifications. |
| Root cause | Other |
| Action | Recall was by scripted telephone conversations to two consignees. Products were returned under RMA. |
| Quantity | 49 |
| Distribution | Arizona, California, Idaho, New York, Texas, and Virginia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000666 | TC-PLUS SOLUTION KNEE Plus Orthopedics, Oct 13, 2000 |