Recall Z-0533-2013 ยท MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid a
| Date | Dec 17, 2012 (initiated Nov 15, 2012) |
| Status | Terminated |
| Reason | Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. This could cause a possible delay in surgery greater than 30 minutes, potentially exposing the patient to the increased risks from being under anesthesia for a longer duration. |
| Root cause | Employee error |
| Action | Biomet Recall sent an Urgent Medical Device Recall Notices letter dated November 15, 2012 to distributors, hospital operating room(OR)managers and Surgeons receiving the affected product. The letter identified the affected product, the reason for the recall and actions to be take, including directions to immediately locate and discontinue use of the affected product. Customers were asked to confirm receipt of the notice by calling 1-888-348-9500 extension 1570. Customers with affected product to be returned are asked to obtain RGA # by calling 574-372-6677 or email: rgarequest@biomet.com. |
| Quantity | 200 |
| Distribution | Worldwide distribution - USA (nationwide) and the countries of Australia, Canada, Chile, Europe, Japan, Korea, Panama, Puerto Rico and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010212 | OFFSET TIBIAL TRAY Biomet, Inc., Feb 14, 2001 |