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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Interlok 67 mm Fixed Cruciate Tibial Plate

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 Class 2 Recall
Biomet Interlok 67 mm Fixed Cruciate Tibial Plate
see related information
Date Posted November 24, 2007
Recall Status1 Terminated on June 04, 2008
Recall Number Z-0255-2008
Recall Event ID 45327
Premarket Notification
510(K) Number
K915132 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product 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
Code Information Lot 626520.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46581-0587
Manufacturer Reason
for Recall
Mislabeled as to size: the package actaully contained a 71 mm tray.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 in Commerce 7
Distribution Nationwide : Distributors in Georgia, Kentucky, Texas and Washington.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = BIOMET, INC.
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