Class 2 Device Recall 16mm Chisel Blade

• Date Initiated by Firm: June 24, 2015
• Date Posted: July 16, 2015
• Recall Status: Terminated on August 18, 2016
• Recall Number: Z-2086-2015
• Recall Event ID: 71599
• Product Classification: Chisel, surgical, manual - Product Code FZO
• Product: 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.
• Code Information: Part Number 399.56 Lot Numbers T106341
• Recalling Firm/ Manufacturer: Synthes (USA) Products LLC; 1301 Goshen Pkwy; West Chester PA 19380-5986
• For Additional Information Contact: Customer Support; 610-719-6500
• Manufacturer Reason for Recall: It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.
• FDA Determined Cause: Employee error
• Action: DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated June 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recipients were asked to check inventory and return affected devices along with the completed response form. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
• Quantity in Commerce: 100
• Distribution: US Distribution to the states of : NJ, VA, OH, IN, MI, FL, WI, CA, TN, MD, NC, WA, UT, ID, MO, NV and KS.
• 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.