Events

Recall of Stryker Torque Wrench

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
    16051
  • Event Initiated Date
    2014-01-22
  • 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
    Manufacturer previously initiated a lot specific recall (ref #15444) after reports received that the hex tip of the torque wrench of an identified lot number subset had been fracturing during final tightening.The establised cause for the fracture was due to grain boundary attack as a result of the heat treat process. since that time additional testing has continued and the manufacturer has made the decision to distribute a recall letter to all customers that have a procedure pack in their possession that may contain the affected product and inform them of the recall expansion. additionally the manufacturer has confirmed that the supplier will use a new heat treatment vendor for which there is a validated heat treatment process., 31/07/2015 - identified that lot 11e035 was not previous included in the recall letters associated with this recall. recall letter updated to include all affected lots and attached a list of all current locations.
  • Action
    Product to be returned to supplier

Device

Stryker Torque Wrench
  • Model / Serial
    Model: Xia 03807028, Xia 3 48237028, Mantis Redux 48287028, Affected: 092793, 098525, 11A957, 11E035, 11E039, 11E042, 11E045, 11E046, 11E047 , 123746, 127051 and R11E036
  • Manufacturer
    Stryker Spine SAS

Manufacturer

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