Events

Recall of Apex Modular Hip Stem Size 4/11.5 (Internal joint prosthesis, femoral component)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Global Manufacturing Technology 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-00791-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00791-3
  • 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
    There was a possibility that the bolt used to secure the stem and neck of the apex modular hip may not have been included with the packaging prior to sterilisation and dispatch.
  • Action
    Quarantine and return affected devices to Global Orthopaedic Technology for replacement with unaffected stock.

Device

Apex Modular Hip Stem Size 4/11.5 (Internal joint prosthesis, femoral component)
  • Model / Serial
    Apex Modular Hip Stem Size 4/11.5 (Internal joint prosthesis, femoral component)Catalogue Number: 151154Lot Number: 113MS1ARTG Number: 120787
  • Manufacturer
    Global Manufacturing Technology Pty Ltd

Manufacturer

Global Manufacturing Technology Pty Ltd