Events

Recall of Modular Finishing Instrument Tray Assembly (used to store, transport and organise instrumentation for the Restoration Modular Instruments Set)

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-01246-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01246-1
  • 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 that the trays of the affected lot number are missing two of the four necessary cut outs. these cut outs provide clearance to secure the clips on the tray lid to the base. the hazard identified is the potential for the blue wrap to tear as a result of the protruding unsecured clips, making the contents of the tray unsterile. a potential tear would likely be noticed by the surgical staff before the instrument is used as the blue wrap is checked for any defects prior to surgery.
  • Action
    Stryker is advising users to remove any affected trays from use. Any affected trays will the replaced by Stryker.

Device

Modular Finishing Instrument Tray Assembly (used to store, transport and organise instrumentation...
  • Model / Serial
    Modular Finishing Instrument Tray Assembly (used to store, transport and organise instrumentation for the Restoration Modular Instruments Set)Catalogue Number: 62789970Lot Number: 039980ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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