Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. 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).
FDA Recall Z-0781-2013 · Posted 2013-02-04
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Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeKWQ
Date Initiated2012-08-06
Date Terminated2015-08-31
Product Quantity63
Reason for Recall
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.
Firm Action
Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated August 6, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 610-719-5450 for questions related to this notice.
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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