Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Synthes(R) Spine Vectra, VectraT and VectraOne Anterior Cervical Plating 2.5mm Drill Bit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Synthes(R) Spine Vectra, VectraT and VectraOne Anterior Cervical Plating 2.5mm Drill Bit see related information
Date Initiated by Firm August 06, 2012
Date Posted February 04, 2013
Recall Status1 Terminated 3 on August 31, 2015
Recall Number Z-0781-2013
Recall Event ID 62943
510(K)Number K050451  K071667  K051665  
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 - 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).
Code Information 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011 - Lots 5443576, 5522810, 5537042, 5557902
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 2		 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 63
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 and Original Applicant = SYNTHES SPINE
510(K)s with Product Code = KWQ and Original Applicant = SYNTHES SPINE CO.LP
-
-