Events

Recall of Device Recall Integra Licox

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
    54769
  • Event Risk Class
    Class 2
  • Event Number
    Z-1422-2010
  • Event Initiated Date
    2010-02-18
  • Event Date Posted
    2010-04-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89131
  • 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
    brain oxygen probe - Product Code GWM
  • Reason
    One probe that had failed a product release test was inadvertently packaged and released into inventory in integra's distribution center.
  • Action
    An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter.

Device

Device Recall Integra Licox
  • Model / Serial
    Catalog number CC1P1, Serial number SN 776; Lot number 160110A
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    One hospital in Omaha, NE.
  • Product Description
    Integra, Licox Ref 1P2.P; || Brain PMO-Probe Kit || Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes, || REF CC1/P1 Combined Oxygen & Temperature Probe. || Contents Sterile and Non-Pyrogenic if package is unopened and undamaged.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.