Events

Recall of Crutches - Forearm Ergo Grip Tall and Forearm Ergo Grip Adult (one arm, walking aid crutch)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Making Life Easy Mobility And Independent Living Superstore 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-01036-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01036-1
  • 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
    Making life easy has received notification of 5 reports with the product whereby a plastic connecting arm appears to have separated from the cuff (plastic insert) of the crutch.
  • Action
    Return affected devices to place of purchase or rental for refund or replacement. For more details, please see http://www.tga.gov.au/safety/alerts-device-mle-forearm-crutch-121213.htm

Device

Crutches - Forearm Ergo Grip Tall and Forearm Ergo Grip Adult (one arm, walking aid crutch)
  • Model / Serial
    Crutches - Forearm Ergo Grip Tall and Forearm Ergo Grip Adult (one arm, walking aid crutch)Crutches - Forearm Ergo Grip TallPart code: 251097Serial numbers: 1202-1 and 1203-1Crutches - Forearm Ergo Grip AdultPart code: 234354Serial numbers: 1202-1 and 1203-1ARTG Number: 138792
  • Manufacturer
    Making Life Easy Mobility And Independent Living Superstore Pty Ltd

Manufacturer

Making Life Easy Mobility And Independent Living Superstore Pty Ltd