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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by Anderson and d'Alonzo.
Recall Number Z-1016-2013
Classification Class II
Code Info Part number 687.030, All Lots
Product Distributed Qty 148
Reason For Recall The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw fixation therefore the affected product will be removed.

Event Detail

Event Id 64271
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 2013-01-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, KS, KY, LA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, TN, TX, VA, VT, WI, WV, and WY.
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