Events

Recall of Device Recall Integra(R) Jarit(R) Monopolar Cable

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64357
  • Event Risk Class
    Class 2
  • Event Number
    Z-0886-2013
  • Event Initiated Date
    2013-02-12
  • Event Date Posted
    2013-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115922
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Coagulator-cutter, endoscopic, unipolar (and accessories) - Product Code KNF
  • Reason
    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.
  • 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.

Device

Device Recall Integra(R) Jarit(R) Monopolar Cable
  • Model / Serial
    Catalogue No. 600-290. All lots distributed since 2004.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including Canada.
  • Product Description
    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.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.