Events

Recall of Star Drive Frame Adapters and Positioners (intended to be used with stereotactic systems for neurosurgical procedures for accurate positioning of mircoelectrodes, stimulating electrodes or other instruments in the brain or nervous system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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
    RC-2013-RN-01134-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01134-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The manufacturer, fhc inc, has received two reports where the 5-hole metal insert of the frame adapter or positioner became loose. in both instances, the insert did not fall completely out of metal housing but loosened within the adapter. neither event resulted in patient injury. such looseness may result in a slight axial movement of the insert although fhc has not identified any significant patient risk as a result of this movement.
  • Action
    Users are advised to contact Emergo Australia to arrange for the return of affected devices to the manufacturer, FHC Inc, for repair. There are loan kits available for use until the devices are corrected.

Device

Star Drive Frame Adapters and Positioners (intended to be used with stereotactic systems for neur...
  • Model / Serial
    Star Drive Frame Adapters and Positioners (intended to be used with stereotactic systems for neurosurgical procedures for accurate positioning of mircoelectrodes, stimulating electrodes or other instruments in the brain or nervous system)Model Numbers: 70-LG-01, 70-FA-RD, 70-FA-LXSerial Numbers: 10205, 00001, 00002, 126279, 126314ARTG Number: 177545
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia