Events

Recall of Head Fixation Device (HFD100) Starburst adaptor thumb screw

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

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
    77996
  • Event Risk Class
    Class 2
  • Event Number
    Z-3211-2017
  • Event Initiated Date
    2017-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158467
  • 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
    Holder, head, neurosurgical (skull clamp) - Product Code HBL
  • Reason
    Incorrect thread on thumbscrews.
  • Action
    The firm notified the consignees by email on 08/14/2017. The letter stated that the screws would be replaced.

Device

Head Fixation Device (HFD100) Starburst adaptor thumb screw
  • Model / Serial
    Serial Numbers: 10006657, 10006658, 10006725, 10006660, 10006726, 10006659
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    IL, OR, PA
  • Product Description
    IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
  • Manufacturer
    Deerfield Imaging

Manufacturer

Deerfield Imaging