Class 2 Device Recall Synthes(R) Spine Vectra, VectraT and VectraOne Adjustable Drill Stop

• Date Initiated by Firm: August 06, 2012
• Date Posted: February 04, 2013
• Recall Status: Terminated on August 31, 2015
• Recall Number: Z-0782-2013
• Recall Event ID: 62943
• 510(K)Number: K050451 K051665 K071667
• Product Classification: Appliance, fixation, spinal intervertebral body - Product Code KWQ
• 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).
• Code Information: Adjustable Drill Stop, Part Number 03.613.012 - Lots 5456424, 5494147, 5557938, and 5557939
• Recalling Firm/ Manufacturer: Synthes USA HQ, Inc.; 1302 Wrights Ln E; West Chester PA 19380-3417
• For Additional Information Contact: Customer Support; 610-719-5000
• Manufacturer 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.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWQ; 510(K)s with Product Code = KWQ