Events

Recall of Stryker Guide Wires and K-Wires for T2 and gamma Systems

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

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
    19630
  • Event Initiated Date
    2016-01-05
  • 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
    Pouch seal integrity cannot be guaranteed.
  • Action
    Product to be returned to supplier

Device

Stryker Guide Wires and K-Wires for T2 and gamma Systems
  • Model / Serial
    Model: 01520218S 12106450S 18060050S 18060080S 18060083S 18060084S 18060085S 18060090S 18060093S 1806125oS 18061417S 18063030S 18063031S, Affected:
  • Manufacturer
    Stryker Trauma AG

Manufacturer

Stryker Trauma AG
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA