Events

Recall of Specialty Size 33mm Reduced Diameter Reaming Cutter

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-00659-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00659-1
  • 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 discovered that the specialty 33mm cutter outer diameter was designed too large and would thus prevent the device from passing through the specialty clamping barrel. this may result in the surgery time being extended by up to 15 minutes to retrieve and use an alternative readily available instrument.
  • Action
    Stryker is advising customers to inspect stocks and quarantine any affected units prior to their return to Stryker. This action has been closed-out on 03/02/2017.

Device

Specialty Size 33mm Reduced Diameter Reaming Cutter
  • Model / Serial
    Specialty Size 33mm Reduced Diameter Reaming CutterCatalogue Number: I-K0913DC33All lots affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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