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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Event Detail

Event ID 63126
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA (nationwide) including the states of Ohio, Carolinas and New England.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty. Item 00-6334-062-36, Lot 62023769 Class II Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton. 1 Z-0386-2013