Recall Z-0924-05 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Plus Orthopedics USA
Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807
| Date | Jun 22, 2005 (initiated Jun 3, 2005) |
| Status | Terminated |
| Reason | Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long. |
| Root cause | Other |
| Action | Notification was made by telephone beginning June 2, 2005. Recall is on-going. |
| Quantity | 54 USA 78 Europe |
| Distribution | Idaho, Texas and Virginia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022204 | VKS KNEE SYSTEM Plus Orthopedics, Oct 18, 2002 |