Recall Z-1383-2013 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Orthopedic Alliance LLC
Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm
| 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 | 37 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
| K101670 | UNITED U2 BIPOLAR IMPLANT United Orthopedic Corp., Oct 8, 2010 |