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Synthes USA HQ, Inc. recalls Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set)
Recalled April 3, 2013 · FDA recall Z-1016-2013 · Synthes USA HQ
Hazard
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. · FDA Class II
Units
148
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Synthes USA HQ, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →