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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Series A Thin Patella 25mm, three pegs, Part 184780

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 Class 2 Device Recall Biomet Series A Thin Patella 25mm, three pegs, Part 184780see related information
Date Initiated by FirmOctober 04, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on April 08, 2013
Recall NumberZ-0695-2012
Recall Event ID 60144
510(K)NumberK040770 
Product Classification Prothesis, knee,patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductBiomet Series A Thin Patella size 25mm, three pegs, Part 184780, 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 184780: Lot 357470, 438780, 527760, 633870, 684140, and 710230. 
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information ContactMary 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		Error in labeling
ActionBiomet 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.
DistributionWorldwide 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 CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWH
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