Recall Z-0076-2008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Biomet Orthopedic, Inc.
| Date | Oct 31, 2007 (initiated Jul 24, 2007) |
| Status | Terminated |
| Reason | Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm. |
| Root cause | Labeling mix-ups |
| Action | The firm notified distributor by phone on or about 7/24/07 and followed up with an Urgent Medical Device Recall Notice/Letter dated 8/31/07. The letter requested that the product be discontinued and returned to Biomet. |
| Quantity | 4 |
| Distribution | Class II Recall - Worldwide Distribution --- USA including states of IA, SD, and countries of Brazil and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K921182 | ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT Biomet, Inc., Jul 23, 1993 |