Events

Recall of Allen Medical Bow Frame

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

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-2017-RN-01421-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01421-1
  • 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
    Allen medical has become aware of a potential risk, which could result in critical harm to the patient if the base of the bow frame were to crack during use. since the introduction of this product in march 2017, one complaint with no injury has been reported where the base of the frame cracked as the patient was being prepared for surgery.
  • Action
    Allen Medical is advising users to remove affected bow frames from use, until the units are corrected.

Device

Allen Medical Bow Frame

Manufacturer

Denyers Pty Ltd T/a Denyers International