Class 2 Device Recall TLC Self Retaining Retractor System

• Date Initiated by Firm: February 17, 2016
• Create Date: May 05, 2016
• Recall Status: Terminated on October 27, 2016
• Recall Number: Z-1608-2016
• Recall Event ID: 73318
• Product Classification: Retractor - Product Code GAD
• Product: TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
• Code Information: Part #: M0068201750; Part #: M0068201761
• Recalling Firm/ Manufacturer: Applied Medical Technology Inc; 8000 Katherine Blvd; Brecksville OH 44141-4202
• For Additional Information Contact: Mr. Daniel C. Filler; 440-262-2526
• Manufacturer Reason for Recall: The firm received a complaint of an open pouch which breaches the sterilization validation.
• FDA Determined Cause: Packaging
• Action: AMT sent an Urgent Medical Device Recall letter dated February 17, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 440-717-4000.
• Quantity in Commerce: 5,334 units
• Distribution: Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.
• 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.