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U.S. Department of Health and Human Services

Class 2 Device Recall G 7 Acetabular System

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  Class 2 Device Recall G 7 Acetabular System see related information
Date Initiated by Firm November 26, 0013
Date Posted December 13, 2013
Recall Status1 Terminated 3 on September 29, 2014
Recall Number Z-0493-2014
Recall Event ID 66967
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product G7 Acetabular Screw 6.5mmx35mm
Part Number: 010001000
Code Information Lot Numbers: 3070517, 3070528, 3077748, 3077750, 3077751, 3085183, 3105038, 3123395, 3123398, 3123399, 3123400, 3146439, 3165497, 3165498, 3165499, 3165500, 3181736
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label.
FDA Determined
Cause 2		 Labeling Change Control
Action Beginning November 25 Urgent recall electronic notices were sent by Biomet UK to all distributors with hospitals outside the USA notified by ground mail November 27,2013. The notification identified the product and reason for the recall, asking for immediate location and discontinued use of the product and return to Biomet UK, Ltd. Questions can be addressed to Biomet USA at 01 574-372-1570 M-F 8 am to 5 pm.
Quantity in Commerce 532 in USA all under Biomet USA control
Distribution Worldwide Distribution - USA Nationwide and in the countries of Europe, Italy, UK, Australia, Japan. all product in USA is under Biomet control.
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.
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