Recall Z-0255-2008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN 46582
| Date | Nov 24, 2007 (initiated Sep 18, 2007) |
| Status | Terminated |
| Reason | Mislabeled as to size: the package actaully contained a 71 mm tray. |
| Root cause | Labeling mix-ups |
| Action | Consignees were notified via letter dated 9/18/07 to discontinue use of the product and to return it to the firm. |
| Quantity | 7 |
| Distribution | Nationwide : Distributors in Georgia, Kentucky, Texas and Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915132 | MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM Biomet, Inc., Feb 11, 1992 |