Events

Recall of Titanium Fluted Stem Extender (used with Stryker’s Duracon and Scorpio Total Stabiliser Knee Implant Systems and Modular Rotating Hinge (MRH) Knee Implant Systems)

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-2015-RN-01207-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-12-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01207-1
  • 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 of the potential for confusion with regards to the intended use for the titanium fluted stem extender, based on the addition of the text "cemented use only" on the product label. the fixation method of the titanium fluted stem extenders is not restricted in australia, and can be used for cemented or cementless applications, even though the labelling states "cemented use only". as a result, there exists the potential for confusion in the operating theatre, resulting in complications associated with a surgery time of less than five minutes.
  • Action
    Customers are advised to immediately check all stock areas and quarantine any affected item. A Stryker Representative will contact customers to arrange for all affected components to be removed from the facility and arrange for a replacement, as required.

Device

Titanium Fluted Stem Extender (used with Stryker’s Duracon and Scorpio Total Stabiliser Knee Impl...
  • Model / Serial
    Titanium Fluted Stem Extender (used with Stryker’s Duracon and Scorpio Total Stabiliser Knee Implant Systems and Modular Rotating Hinge (MRH) Knee Implant Systems)Multiple Item Numbers and Lot Numbers affectedARTG Number: 242297
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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