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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 65209
Product Type Devices
Status Ongoing
Recalling Firm Biomet, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-26
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed in New York.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty. Part numbers: EP-200162, EP-200162, EP-200164, and EP-200166 with Lot numbers: 027050, 101470, 115950, 101480, 247990, 948810, 967270, 027070, 287820, 729870, and 860880. Class II Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size. 8 units Z-1465-2013