Events

Recall of Device Recall Integra Radionics

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
    57818
  • Event Risk Class
    Class 2
  • Event Number
    Z-1400-2011
  • Event Initiated Date
    2011-01-12
  • Event Date Posted
    2011-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97501
  • 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
    Neurological, sterotaxis instrument - Product Code HAW
  • Reason
    Overall length of the intubation hoop in the hraim intubation head ring assembly is too long and will not allow a device to to attach.
  • Action
    Integra sent a Medical Device Field Corrective Action letter dated January 12, 2011, to all affected customers via Federal Express. Integra Sales Specialists were provided with the replacement part and written instructions on how to replace the affected intubation hoops from customer inventory identified in the traceability report. Upon completion of the field correction each sales specialist was instructed to return the affected hoop along with a completed copy the Recall Acknowledgement and Return Form. If additional information is required contact me at (609) 936-2485 or james.tillman@integraJife.com.

Device

Device Recall Integra Radionics
  • Model / Serial
    Lot/Serial Number(s): 0189463, 0189289, 0186642, 0184885
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, Canada, and Australia
  • Product Description
    Integra Radionics HRAIM Intubation Head Ring Assembly || Ref: HRAIM Head Rings serve as the general stereotactic treatment platform. Head Rings are used to provide a reference frame for instrumentation used for precise spatial localization and treatment of physiologic targets for stereotactic neurosurgical procedures such as craniotomies, biopsies, functional neurosurgery, and radiation therapy. Head Rings are delivered to the user non-sterile, and are reusable.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.