Recall Z-0706-2008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581
| Date | Jan 31, 2008 (initiated Dec 12, 2007) |
| Status | Terminated |
| Reason | Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa. |
| Root cause | Packaging process control |
| Action | Consignees were notified via an Urgent Medical Device Recall Notice dated 12/12/07 to cease use of the product and to return it. |
| Quantity | 8 |
| Distribution | Worldwide: USA including states of Georgia, Idaho, Indiana, Missouri, Ohio, and Virginia and country of Turkey. |
| 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 |