Events

Recall of STAR Instruments Kit, sterile packaged (used to implant Scandinavian Total Ankle Replacement System)

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-01266-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-09-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01266-1
  • 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
    Stryker has become aware during an internal review that some items of the star sterile instrument kit have been unintentionally shipped to australia without being ce marked. non-sterile instrument alternatives are available for the australian market. based on design review by stryker and the availability of the necessary ifu information, no hazards are to be expected.
  • Action
    Customers are advised to inspect the inventory and quarantine any affected stock immediately. A Stryker representative will coordinate the return of any affected product. This action has been closed-out on 11/05/2017.

Device

STAR Instruments Kit, sterile packaged (used to implant Scandinavian Total Ankle Replacement System)
  • Model / Serial
    STAR Instruments Kit, sterile packaged (used to implant Scandinavian Total Ankle Replacement System)Multiple instruments within the STAR Instruments KitItem Number: 100-0071Lot Numbers: 20320, 30332ARTG Number: 240015
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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