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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64357
Product Type Devices
Status Ongoing
Recalling Firm Integra LifeSciences Corp.
City Plainsboro
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-12
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA Nationwide including Canada.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290) Product Usage: Endoscopic Instruments - For use by, or as directed by, a surgeon 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 Cable - Monopolar electrosurgical current can be used for coagulation and/or cutting as determined necessary and appropriate by the surgeon. All lots distributed since 2004 Class II Integra has received complaint reports related to the electrical safety of the monopolar electrosurgical cables. 22,500 Z-0886-2013