FDAFDA · Food and drugs·Recall number Z-0782-2013
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).
Published February 13, 2013 · Recall initiated: August 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- 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.
- Lot
- Adjustable Drill Stop, Part Number 03.613.012 - Lots 5456424, 5494147, 5557938, and 5557939
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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