FDA Recall
Terminated
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
Recall: Z-0255-2008
·
Initiated September 18, 2007
Recall
- Recall Number
- Z-0255-2008
- Event Number
- 45327
- Firm
- Biomet, Inc.
- FEI Number
- 1825034
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- September 18, 2007
- Posted
- November 24, 2007
- Terminated
- June 4, 2008
- Address
- 56 E Bell Dr, Warsaw, IN, 46581-0587
Description
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
Reason
Mislabeled as to size: the package actaully contained a 71 mm tray.
Action
Consignees were notified via letter dated 9/18/07 to discontinue use of the product and to return it to the firm.
Distribution
Nationwide : Distributors in Georgia, Kentucky, Texas and Washington.
Quantity
7