Events

Recall of Xia 3 Titanium Torque Wrench & Xia 3 Titanium Torque Wrench Short (used for final tightening of the blocker on the head of the pedicle screw during posterior spinal fusion surgery)

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-01017-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01017-1
  • 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 spine has received reports that the hex tip of the xia 3 torque wrenches of an identified lot number subset have been fracturing during final tightening. the hex tip of the wrench is broken off and separated from the main tube.
  • Action
    Customers are requested to quarantine all affected lots. A Stryker representative will contact all affected customers to arrange for collection of the Xia 3 Torque Wrench. Unaffected replacement units will be provided.

Device

Xia 3 Titanium Torque Wrench & Xia 3 Titanium Torque Wrench Short (used for final tightening of t...
  • Model / Serial
    Xia 3 Titanium Torque Wrench & Xia 3 Titanium Torque Wrench Short (used for final tightening of the blocker on the head of the pedicle screw during posterior spinal fusion surgery)Xia 3 Titanium Torque WrenchCatalogue #: 48237028 (48230012-T, 48230004-T, 48230012NSW-T, 48230004NZ-T, WKSHP48230004-T)Lot Numbers: 11E042, 11E047Xia 3 Titanium Torque Wrench ShortCatalogue #: 482397028 (HANXIA3-T, HUNTSPINEEXT-T, 482370-T)Lot Numbers: 11E036, R11E036, 11A957ARTG Number: 160151
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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