—#115345

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).

FDA product code: KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K050451, K051665, K071667
Affected lot / code info: Adjustable Drill Stop, Part Number 03.613.012 - Lots 5456424, 5494147, 5557938, and 5557939

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

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.

Timeline

Recall initiated: 2012-08-06
Posted by FDA: 2013-02-04
Terminated: 2015-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115345. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.