Events

Recall of Xia 3 Titanium Torque Wrench

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-00745-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00745-1
  • 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 received reports that the hex tip of the listed torque wrenches have been fracturing during final tightening. the hex tip of the wrench has broken off and separated from the main tube.The manufacturer has identified four possible hazardous situations:· delay in surgery time (< 5 minutes) if an alternative torque wrench is needed· debris of non-implantable grade material falling into the wound· over/under-tightening of the blocker if an alternate instrument is not available· accidental implanting of the hex tip.
  • Action
    Customers are requested to quarantine all affected lots. A Stryker representative will contact all affected customers to arrange for collection of the affected products. Unaffected replacement units will be provided. This action has been closed-out 18/04/2017.

Device

Xia 3 Titanium Torque Wrench
  • Model / Serial
    Xia 3 Titanium Torque WrenchCatalogue Number: 48237028Lot Numbers: 098525, Xia 3 Torque Wrench ShortCatalogue Number: 482397028Lot Numbers: 11E035ARTG Number: 160151
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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