Events

Recall of Head Ring Assembly with Intubation Mounts (HRAIM)

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

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
    62978
  • Event Risk Class
    Class 2
  • Event Number
    Z-2429-2012
  • Event Initiated Date
    2012-08-09
  • Event Date Posted
    2012-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112236
  • 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 stereotaxic Instrument - Product Code HAW
  • Reason
    T-handle screw is used on a complementary product to the crw, the integra hraim, which is the ct-compatible intubation head ring assembly. when the t-handle on the hraim intubation hoop is tightened, the t-handle could stop in a vertical position that prevents the crwprecise and certain models of the crw-asl from seating properly on the head ring although it appears to be fully seated.
  • Action
    The firm, Integra, sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" dated August 10, 2012 to US & Canada consignees/customers via traceable courier service and Non-US & Non-Canada consignees/customers - through written notification delivered either by traceable courier, email, facsimile, or through a directed visit by an Integra Sales Representative. The notification describes the product, problem and actions to be taken. The Integra sales representative will replace the screws according to the attached rework instructions. If for some reason it is not possible to replace the screws during the visit, the sales representative will leave the screws and customers can then replace them by following the attached rework instructions and discard the old screws immediately after replacement. The customers were instructed to complete and return the Product Recall Acknowledgement Form via the sales representatives visit; fax at 1-609-750-7999 or email to: csnirecalls@integralife.com and include the number of devices to be identified and replaced . Note:The T -Handle screws that are replaced will be disposed of at the consignee's/customers location. Please feel free to contact our service hotline at 888-772-7378 should you have any additional questions.

Device

Head Ring Assembly with Intubation Mounts (HRAIM)
  • Model / Serial
    All lot numbers from 2002 to current
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.
  • Product Description
    Integra HRAIM Head Ring Assembly with Intubation Mounts || The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation