Recall Z-1379-2013 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Orthopedic Alliance LLC
Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303-1211 Tibial insert,CR,plained,#1,11mm 2303-1212 Tibial insert,CR,plained,#1,13mm 2303-1213 Tibial insert,CR,plained,#1,15mm 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 | 459 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
| K103733 | UNITED U2 XPE TOTAL KNEE SYSTEM United Orthopedic Corporation, Aug 2, 2011 |