Recall Z-0782-2013 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Synthes USA HQ, Inc.
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).
| Date | Feb 4, 2013 (initiated Aug 6, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| 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. |
| Quantity | 48 |
| Distribution | 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. |
| FDA record | Open on fda.gov |