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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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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
Distribution Pattern All product in USA is under Biomet control; Europe, Italy, UK, Australia, Japan

Product Detail

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