Events

Recall of REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-impaired users to provide enhanced functional mobility for exercise and rehabilitation purposes)

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

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-2016-RN-00852-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00852-1
  • 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
    Rex bionics has been made aware of a patient injury, relating to incorrectly securing the heel stops on the rex. the patient suffered bilateral upper and lower tibial and bilateral lower fibular fractures following a spasm which resulted in unsecured heel stops moving backwards. the injuries may have been exacerbated by the use of ankle foot orthoses (afo) which restricted the users’s range of motion greater than required by rex.The heel stop must be correctly aligned with the measurement on the footplate corresponding to the user’s ankle to hind-foot measurement. once adjusted, the heel stop must be secured by tightening the locking nut. failure to do this may cause the user’s leg to move out of alignment, which may result in serious injury.
  • Action
    Rex Bionics is advising users of the importance of the correct heel stop adjustment, and securing using the tightening of the locking nut. Revised Instructions for Use (IFU) will be provided regarding the heel stops and the use of Ankle Foot Orthoses which limit the range of motion for a patient. This action has been closed out on 16 June 2017.

Device

REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-...
  • Model / Serial
    REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-impaired users to provide enhanced functional mobility for exercise and rehabilitation purposes) All devices affectedARTG Numbers: 237572, 271519
  • Manufacturer
    Rex Bionics Australia Pty

Manufacturer

Rex Bionics Australia Pty
  • Source
    DHTGA