Recall Z-1384-2013 ยท HWC Screw, Fixation, Bone
Orthopedic Alliance LLC
Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.
| 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 | 5 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
This recall record lists no 510(k) number.