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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Recall Number Z-0493-2014
Classification Class II
Code Info Lot Numbers: 3070517, 3070528, 3077748, 3077750, 3077751, 3085183, 3105038, 3123395, 3123398, 3123399, 3123400, 3146439, 3165497, 3165498, 3165499, 3165500, 3181736
Product Distributed Qty 532 in USA all under Biomet USA control
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.

Event Detail

Event Id 66967
Product Type Devices
Status Ongoing
Recalling Firm Biomet, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-26
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern All product in USA is under Biomet control; Europe, Italy, UK, Australia, Japan