Recall of Jenx Ltd Headrest Brackets (An externally applied orthopaedic frame for standing).

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

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-2012-RN-00703-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-10
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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 single prong bracket that attaches to the headrest has broken on two occasions. this resulted in the headrest falling off the product.
  • Action
    Doability is recommending users to implement a work around until replacement brackets can be installed on all affected devices.

Device

  • Model / Serial
    Jenx Ltd Headrest Brackets (An externally applied orthopaedic frame for standing).ARTG Number: 199158
  • Manufacturer

Manufacturer