Recall Z-1381-2013 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Orthopedic Alliance LLC
U2 Acetabular cup, Ti beads porous coated, 44mm U2 Acetabular cup, Ti beads porous coated, 46mm U2 Acetabular cup, Ti beads porous coated, 48mm U2 Acetabular cup, Ti beads porous coated, 50mm U2 Acetabular cup, Ti beads porous coated, 52mm U2 Acetabular cup, Ti beads porous coated, 54mm U2 Acetabular cup, Ti beads porous coated, 56mm U2 Acetabular cup, Ti beads porous coated, 58mm U2 Acetabular cu
| 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 | 30 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
| K121777 | U2 ACETABULAR CUP, PLASMA SPRAY United Orthopedic Corp., Jul 18, 2012 |