Events

Recall of Ceramic Insertion Tool Assembly (Supplied as part of the reusable orthopaedic surgical procedure kit)

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-2013-RN-00114-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00114-1
  • 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
    Preliminary testing by stryker orthopaedics indicates that some silicone suction cup sub-component were manufactured from a non-silicone polymer, polyvinyl chloride (pvc) and that these pvc cups contain latex.
  • Action
    Stryker is requesting customers to identify and remove any affected stock until the units can be collected or returned to Stryker

Device

Ceramic Insertion Tool Assembly (Supplied as part of the reusable orthopaedic surgical procedure ...
  • Model / Serial
    Ceramic Insertion Tool Assembly (Supplied as part of the reusable orthopaedic surgical procedure kit)Catalogue number: 2216-0005All lot numbers are affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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