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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Product Detail

Product Description Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
Recall Number Z-0452-2014
Classification Class II
Code Info Part # 456.391S with lot numbers 5536930, exp. 5/20/2016, and 7161401, exp. 12/31/2021.
Product Distributed Qty 17
Reason For Recall Three lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.

Event Detail

Event Id 66417
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 2013-07-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.