Recall Z-0397-06 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Plus Orthopedics USA
VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)
| Date | Jan 18, 2006 (initiated Dec 2, 2005) |
| Status | Terminated |
| Reason | The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happend during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification. |
| Root cause | Other |
| Action | The adjustment know tower on one device was found t have broken off from the body of the instrument. This did not happend during a surgery, and is belived tohave been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification. |
| Quantity | 14 |
| Distribution | Arizona, California, Colorado, Idaho, New York, Oklahoma, Texas, Utah, Wisconsin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022204 | VKS KNEE SYSTEM Plus Orthopedics, Oct 18, 2002 |