Events

Recall of Kidwalk Dynamic Mobility System, model number: KW01 (A wheeled support frame intended to assist a disabled child in walking by providing a means of support)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Otto Bock Australia 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-00669-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00669-3
  • 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 tga received an incident report and examined a kidwalk mobility aid, which had failed at the base of the mast. tga’s investigation recommended to reinforce and update three important points in the owner’s manual (instructions for use) for the kidwalk with aluminium mast supplied prior to december 2010:· considerations on re-issue of the kidwalk.· regular inspection and annual service of the kidwalk · the intended purpose of the kidwalk.
  • Action
    Update to the Instructions for Use (IFU).

Device

Kidwalk Dynamic Mobility System, model number: KW01 (A wheeled support frame intended to assist a...
  • Model / Serial
    Kidwalk Dynamic Mobility System, model number: KW01 (A wheeled support frame intended to assist a disabled child in walking by providing a means of support)Supplied prior to December 2010Model Number: KW01ARTG Number: 175458
  • Manufacturer
    Otto Bock Australia Pty Ltd

Manufacturer

Otto Bock Australia Pty Ltd