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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet CC Cruciate Tibial Tray

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 Class 2 Recall
Biomet CC Cruciate Tibial Tray
see related information
Date Posted January 31, 2008
Recall Status1 Terminated on June 11, 2008
Recall Number Z-0707-2008
Recall Event ID 46141
Premarket Notification
510(K) Number
K915132 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Biomet, Inc., Warsaw, IN 46581
Code Information Lot Number: 448740.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46581-0587
Manufacturer Reason
for Recall
Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
FDA Determined
Cause 2
DESIGN: Software Design
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 in Commerce 8
Distribution Worldwide: USA including states of Georgia, Idaho, Indiana, Missouri, Ohio, and Virginia and country of Turkey.
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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