Events

Recall of Crocodile Size 3 Walker (walking aid)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by R82 AU 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-2013-RN-00931-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00931-1
  • 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
    The manufacturer r82 a/s have been informed about breakage of the bolt attaching the handle to the fram on crocodile 3. to eliminate such breakages that lead to the handle falling off they are now using a 8.8 bolt instead of the initial 12.9 hardened bolt. such bolts are now being sent out for retrofitting on units already on the market.This recall action was carried out prior to approval of the recall strategy by the tga.

Device

Crocodile Size 3 Walker (walking aid)
  • Model / Serial
    Crocodile Size 3 Walker (walking aid)Serial Number: 86803
  • Manufacturer
    R82 AU Pty Ltd

Manufacturer

R82 AU Pty Ltd