| | Class 2 Recall
Biomet Offset Tibial Tray Adaptor |  |
| Date Posted |
December 17, 2012 |
| Recall Number |
Z-0533-2013 |
| Product |
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 arthritis, traumatic arthritis when one or more compartments are involved, 2) correction of varus, valgus, or posttraumatic deformity, 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure |
| Code Information |
Catalog Number: 141490
Lot 378330,378320,407230,485010,505140,485000,506070,533400,54048, 439700,797820
|
Recalling Firm/
Manufacturer |
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989 |
| For Additional Information Contact |
Audrey Daenzer
574-372-1570
|
Reason for
Recall |
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.
|
| 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. A FAX Back Response Form is to be filled out and sent within 3 days of receipt to 574-372-1683. Return product to the Attention of Audrey Daenzer, Field Action Coordinator, Biomet, Attention Return Goods, Building B Recalls, 56 East Bell Drive, Warsaw, IN 46580. Questions related to the notice should be directed to 474-372-3983 or 574-371-3009, Monday- Friday 8 a.m. to 5 p.m. |
| Quantity in Commerce |
200 |
| Distribution |
Worldwide distribution - USA (nationwide) and the countries of Australia, Canada, Chile, Europe, Japan, Korea, Panama, Puerto Rico and Thailand. |
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