Class 2 Device Recall Integra(R) Jarit(R) Monopolar Cable

• Date Initiated by Firm: February 12, 2013
• Date Posted: February 26, 2013
• Recall Status: Terminated on December 24, 2013
• Recall Number: Z-0886-2013
• Recall Event ID: 64357
• 510(K)Number: K932456
• Product Classification: Coagulator-cutter, endoscopic, unipolar (and accessories) - Product Code KNF
• Product: Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.
• Code Information: Catalogue No. 600-290. All lots distributed since 2004.
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: David E. Gronostajski; 609-275-0500
• Manufacturer Reason for Recall: Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautions that are applicable to the use of electrosurgical equipment in health care facility environments.
• FDA Determined Cause: Other
• Action: Integra sent an Urgent Medical Device Correction Field Safety Notice letter dated February 12, 2013 and a copy of the Instructions for Use addendum to all affected customers. The letter identified the product, nature of the issue and actions to be taken. Customers were requested to examine their inventory for the affected product and include a copy of the addendum to that inventory. Customers were instructed to complete and return the Acknowledgement Return Form and provide a copy of the IFU addendum to any of their customers that had purchased the Jarit(R0 Monopolar Cable. For questions call Integra Surgical Customer Service at 800-431-1123.
• Quantity in Commerce: 22,500
• Distribution: Worldwide Distribution - USA Nationwide including Canada.
• 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 = KNF