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