Events

Recall of Xia 3 Torque Wrench and Mantis Redux Torque Wrench (Supplied as part of Xia 3 instrument tray)

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-2012-RN-00830-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00830-3
  • 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 spine has become aware that instruments of the affected lot may fracture at the hex tip of the torque wrench during final tightening.
  • Action
    Review the Xia 3 instrument trays for the affected wrenches. All affected wrenches must be removed and quarantined until collected or returned.

Device

Xia 3 Torque Wrench and Mantis Redux Torque Wrench (Supplied as part of Xia 3 instrument tray)
  • Model / Serial
    Xia 3 Torque Wrench and Mantis Redux Torque Wrench (Supplied as part of Xia 3 instrument tray) Xia 3 Torque WrenchCatalogue Number: 48237028Lot Number: 093655Mantis Redux Torque WrenchCatalogue Number: 48287028Lot Number: 098400(Supplied as part of Xia 3 instrument tray) ARTG number: 160151Instrument Tray Number: 48230012-T, 48230004-T, 48289001-T
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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