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Synthes USA HQ, Inc. recalls Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Par
Recalled February 13, 2013 · FDA recall Z-0782-2013 · Synthes USA HQ
Hazard
Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. · FDA Class II
Units
48
Sold at
Nationwide Distribution-including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
Description
Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.
Product
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Manufacturer(s)
Synthes USA HQ, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →