Events

Recall of Stryker Xia 3 Titanium Torque Wrench Short

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Stryker Spine SAS.

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
    15444
  • Event Initiated Date
    2013-10-08
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    Stryker 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
    Product to be exchanged

Device

Stryker Xia 3 Titanium Torque Wrench Short
  • Model / Serial
    Model: Catalogue Numbers: 482397028 (HANXIA3-T, HUNTSPINEEXT-T, 482370-T), Affected: Lot Numbers: 11E036, R11E036, 11A957
  • Manufacturer
    Stryker Spine SAS

Manufacturer

Stryker Spine SAS
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA