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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Series A Asymmetrical Patella size 28mm, three pegs 184791

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 Class 2 Recall
Biomet Series A Asymmetrical Patella size 28mm, three pegs 184791
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on April 08, 2013
Recall Number Z-0704-2012
Recall Event ID 60144
Premarket Notification
510(K) Number
K040770 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Biomet Series A Asymmetrical Patella size 28mm, three pegs - 184791, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
Code Information Part 184791, Lot 098760, 143320, 143480, 247410, 247420, 283590, 311990
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
For Additional Information Contact Mary Hardesty
574-371-3755
Manufacturer Reason
for Recall
Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Biomet sent a "FIELD CORRECTION NOTICE" dated October 3, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate the affected product and to follow the work instructions included in the letter. Additionally, a Confirmation of Completion Response Form was enclosed for customers to complete and return via fax to 574-372-1683. Questions related to this notice are directed to 574-371-3755.
Distribution Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Argentina, Australia, Canada, Chile, Costa Rica, Europe, India, Japan, Korea, and Singapore.
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 MANUFACTURING, INC.
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