Events

Recall of KA351 - My Mobility Walking Frame with Front Wheels, Large, Aluminium, APO Grey, and KA351SG - My Mobility Walking Frame with Front Wheels and Star Glides, Large, Aluminium, APO Grey

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by K Care 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-2015-RN-00277-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00277-1
  • 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
    K care received complaint that the new walking frame has fallen apart while been used by a patient. on examination, 14 walking frames were found to be faulty. k care decided to remove all frames with a white expander connection, as it was apparent they were a different product from the frames that were from earlier deliveries, with a grey expander connector.The material composition of the pintel that connected the horizontal rail to the vertical leg had been changed. the new composition material (white) was too soft and did not retain its integrity when the nut was tightened.
  • Action
    K Care sales representatives contacted all the customers. All the affected products are corrected. K Care sales representatives also checked the potentially affected products of the model supplied and confirmed that the products are not affected.

Device

KA351 - My Mobility Walking Frame with Front Wheels, Large, Aluminium, APO Grey, and KA351SG - My...
  • Model / Serial
    KA351 - My Mobility Walking Frame with Front Wheels, Large, Aluminium, APO Grey, and KA351SG - My Mobility Walking Frame with Front Wheels and Star Glides, Large, Aluminium, APO GreyModel Numbers:KA351 & KA351SGARTG Number: 209821
  • Manufacturer
    K Care Pty Ltd

Manufacturer

K Care Pty Ltd
  • Source
    DHTGA