Events

Recall of Device Recall Integra(TM) Jarit(R) TakeApart Endoscopic Instruments

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

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
    62464
  • Event Risk Class
    Class 2
  • Event Number
    Z-2028-2012
  • Event Initiated Date
    2012-05-23
  • Event Date Posted
    2012-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110714
  • 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
    The integra(tm) jarit(r) take-apart laparoscopic instrument shafts were released with internal component out of specification.
  • Action
    Integra sent a Urgent Field Corrective Action letter dated May 23, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed customers and sales reps to return the instruments identified on the attached part number list and complete a "Field Corrective Action Acknowledgement and Return Form" to be completed and returned to the firm. We apologize for any inconvenience this issue may cause you. Please call Integra Surgical Customer Service at 800-431-1123 if you have any questions.

Device

Device Recall Integra(TM) Jarit(R) TakeApart Endoscopic Instruments
  • Model / Serial
    Model number 643350 -- batch numbers 1045878, 1045879, 1045881, 1045880, 1045872, 1045882, 1045876, 1045877, 1045873, 1045874, and 1045875. Model number 643425 -- batch numbers 1045890, 1045886, 1045884, 1045887, 1045888, 1045889, and 1045885. Model number 643650 -- batch numbers 1045891, 1045892, and 1045893. Model number 643725 -- batch numbers 1045894 and 1045895.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.
  • Product Description
    Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. || Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon.
  • Manufacturer
    Integra Limited

Manufacturer

Integra Limited
  • Manufacturer Address
    Integra Limited, 311 Enterprise Dr, Plainsboro NJ 08536-3344
  • Source
    USFDA