Events

Recall of Device Recall Integra Life Sciences Ojemann Cortical Stimulator

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

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
    64665
  • Event Risk Class
    Class 2
  • Event Number
    Z-1030-2013
  • Event Initiated Date
    2013-03-18
  • Event Date Posted
    2013-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116735
  • 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
    Electrode, cortical - Product Code GYC
  • Reason
    If the headphone jack is in use during a surgical procedure with the ocs2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury.
  • Action
    Integra initiated a voluntary recall on March 18, 2013 by providing written notification to consignees either by traceable courier service or traceable emails regarding the correction that Integra records indicate have an OCS2 since it was introduced to the market in 2007. The consignee notification: Advised of the nature of the issue and to immediately stop using the headphone jack while using the OCS2. Requested identification by S/N any OCS2's they have, and complete / return the Acknowledgment Return Form. Advised that Integra will contact the consignee to schedule a time / date to correct the OCS2's they have identified. Questions, contact service hotline at 1-888-772-7378.

Device

Device Recall Integra Life Sciences Ojemann Cortical Stimulator
  • Model / Serial
    Serial Number Range: 1010 through 1380
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Belgium, Denmark, Spain, Great Britain, Hungary, Ireland, Italy, Netherlands, Poland, Morocco, Netherlands, Poland, Portugal, Saudia Arabia, Sweden, Turkey, and South Africa.
  • Product Description
    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. || Intended for intraoperative cortical stimulation mapping procedures.
  • Manufacturer
    Integra Burlington MA, Inc.

Manufacturer

Integra Burlington MA, Inc.