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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Vanguard DCM PS Plus Tibial Bearing.

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 Class 2 Recall
Biomet Vanguard DCM PS Plus Tibial Bearing.
see related information
Date Posted November 21, 2008
Recall Status1 Terminated on September 22, 2009
Recall Number Z-0289-2009
Recall Event ID 49867
Premarket Notification
510(K) Number
K041046 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet Orthopedics, Inc., Warsaw, IN. A knee prosthesis intended for single use implantation to replace the articular portions of the knee joint.
Code Information Lots 713910, 806560, 816560 and 871750.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582
Manufacturer Reason
for Recall
The package is properly labeled, but the laser etch for size incorrectly reads "16 X 63/63" instead of the correct size, "16 X 63/67".
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action A notification letter (Urgent Medical Device Removal Notice) dated 9/22/08 was sent to the firm's sales staff with instructions to locate and retrieve the product and to notify customers at affected hospitals of the problem. Questions related to this notice should be directed to the Biomet Orthopedics, LLC Corrective Actions Manager at 800-348-9500 or 574-372-3983, Monday through Friday, 8 A.M. to 5 P.M. (EST).
Quantity in Commerce 11
Distribution Worldwide Distribution: USA including states of Florida, New Jersey, Maryland, Pennsylvania, South Carolina, South Dakota, and Virginia, and country of Finland.
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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