Class 2 Device Recall Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Col

• Date Initiated by Firm: January 11, 2013
• Date Posted: March 28, 2013
• Recall Status: Terminated on September 10, 2015
• Recall Number: Z-1016-2013
• Recall Event ID: 64271
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by Anderson and d'Alonzo.
• Code Information: Part number 687.030, All Lots
• FEI Number: 3005180112
• 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: The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw fixation therefore the affected product will be removed.
• FDA Determined Cause: No Marketing Application
• Action: Synthes sent an Urgent Notice Medical Device Recall letter dated January 11, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory, remove the recalled product from use and return it to Synthes. Customers were asked to completed the attached verification Section at the end of the letter by checking the appropriate box indicating that no affected product had been located and fax to 610-251-9005. For questions customers were instructed to call 610-719-5450 or email at FieldAction@synthes.com. For questions regarding this recall call 610-719-5000.
• Quantity in Commerce: 148
• Distribution: Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, KS, KY, LA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, TN, TX, VA, VT, 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.