Recall Z-0361-2008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Plus Orthopedics USA
VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121
| Date | Dec 8, 2007 (initiated Nov 13, 2006) |
| Status | Terminated |
| Reason | Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert. |
| Root cause | Employee error |
| Action | Consignees were notified by telephone on 11/13/2006 to check their inventory and return any affected units. On 11/28/06 Physician Notifications and Patient Assessment forms were sent to the two physicians who had implanted a total of 4 devices. |
| Quantity | 10 |
| Distribution | Nationwide: USA including states of ID, NY, VA & WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022204 | VKS KNEE SYSTEM Plus Orthopedics, Oct 18, 2002 |