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U.S. Department of Health and Human Services

Class 2 Device Recall Vanguard PS Open Box Femoral 70MM Left Interlok

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  Class 2 Device Recall Vanguard PS Open Box Femoral 70MM Left Interlok see related information
Date Initiated by Firm July 06, 2011
Date Posted August 04, 2011
Recall Status1 Terminated 3 on September 26, 2012
Recall Number Z-2945-2011
Recall Event ID 59058
510(K)Number K023546  
Product Classification Knee Prosthesis, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY.
Biomet, Inc.

A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.
Code Information Part # 183132.  Lot # 947480.  
Recalling Firm/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Biomet Customer Service
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall
The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.
FDA Determined
Cause 2
Employee error
Action Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers. The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to quarantine and return the devices, and a return form. For information or questions on this recall call Biomet at (574) 371-3756.
Quantity in Commerce 8
Distribution Worldwide Distribution: (USA) Nationwide including the states of NJ, PA, LA, SD, TX, and KS; and the country of The Netherlands.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JWH and Original Applicant = BIOMET, INC.