Class 2 Device Recall Integra LifeSciences

• Date Initiated by Firm: March 07, 2016
• Date Posted: May 31, 2016
• Recall Status: Terminated on March 31, 2017
• Recall Number: Z-1867-2016
• Recall Event ID: 73684
• 510(K)Number: K993655
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
• Code Information: Catalogue No: CEV669E. All batch numbers distributed from January 2011 to February 17, 2016.
• FEI Number: 3003418325
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: Mr. David E. Gronostajski; 609-936-6822
• Manufacturer Reason for Recall: Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
• FDA Determined Cause: Other
• Action: Integra sent an "Urgent Medical Device Correction" Field Safety Notice and an addendum dated March 7, 2016 to their customers via traceable courier service.
• Quantity in Commerce: 2,487 Instruments
• Distribution: AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI
• 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 = GEI