Recall Z-1378-2013 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Orthopedic Alliance LLC
Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral component, CR, cemented, #6, left 2103-1360 Femoral component, CR, cemented, #1, right 2103-1410 Femoral component, CR, cemented, #2
| Date | May 24, 2013 (initiated Feb 20, 2013) |
| Status | Terminated |
| Reason | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
| Root cause | Labeling design |
| Action | A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature. |
| Quantity | 136 units |
| Distribution | Nationwide Distribution including the states of CA, MD, TX, NV, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120507 | UNITED U2 FEMORAL COMPONENT, PS, #7 United Orthopedic Corporation, May 4, 2012 |