Events

Recall of Cancellous Bone Screws 16mm, 20mm, 25mm, 30mm, 35mm, 45mm, 50mm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2016-RN-01616-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-12-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01616-1
  • 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
    A complaint has been received that on the box label, the country of manufacture ("made in usa") was incorrectly labelled as “made in switzerland” and was missing the ce mark as well as the european authorised representative (“ec rep”) address.
  • Action
    Stryker is advising customers with affected stock to return them for replacement or credit.

Device

Cancellous Bone Screws 16mm, 20mm, 25mm, 30mm, 35mm, 45mm, 50mm
  • Model / Serial
    Cancellous Bone Screws 16mm, 20mm, 25mm, 30mm, 35mm, 45mm, 50mmItem Numbers: 203065161, 203065201, 203065251, 203065301, 203065351, 203065451, 203065501 Multiple Lot NumbersARTG Number: 242299
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA