Events

Recall of Apex Knee System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Global Orthopaedic 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-2017-RN-01490-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-12-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01490-1
  • 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 apex knee system tibial baseplate identified has an improper expiration date marked on the external packaging. the improper expiration date (2202-03) is marked on the external packaging only. the correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.This action has been undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    Global Orthopaedic has advised users to quarantine and return all unused devices.

Device

Apex Knee System

Manufacturer

Global Orthopaedic Technology Pty Ltd