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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Vanguard DCM CR Tibial Bearing

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 Class 2 Recall
Biomet Vanguard DCM CR Tibial Bearing
see related information
Date Posted July 25, 2008
Recall Status1 Terminated on December 22, 2009
Recall Number Z-1376-2008
Recall Event ID 46708
Premarket Notification
510(K) Number
K023546 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Biomet Vanguard DCM CR Tibial Bearing, 14MM x 79/83MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183464.
Code Information Lot 743470.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46581-0587
For Additional Information Contact Mary Hardesty
800-348-9500
Manufacturer Reason
for Recall
Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Distributors were notified via recall letter (Urgent Medical Device Removal Notice) dated 2/12/08 to locate the devices in their possession and at hospital sites, discontinue use, and return them to Biomet. Hospitals having received the devices will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. A third letter dated 2/12/08 was provided for implanting physicians.
Quantity in Commerce 8
Distribution Worldwide: USA and Australia
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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