Recall Z-0540-05 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Plus Orthopedics
UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
| Date | Feb 15, 2005 (initiated Jan 4, 2005) |
| Status | Terminated |
| Reason | Knee tibial insert is mislabeled completely as different device. |
| Root cause | Other |
| Action | PLUS Orthopedics QA department has identified a labeling eror on Article 0214703, affecting lot number 044843. This Ultra-congruent PE insert package may contain a Standard PE insert. |
| Quantity | 10, 1 is implanted. |
| Distribution | California, Idaho, Illinois, Wisconsin, Oregon |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022204 | VKS KNEE SYSTEM Plus Orthopedics, Oct 18, 2002 |