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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 64406
Product Type Devices
Status Ongoing
Recalling Firm Synthes USA HQ, Inc.
City West Chester
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-18
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed in MA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device. Part Number 450.851S, Lot Number 7065061 Class II Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed. 1 Z-2243-2013