Events

Recall of Stryker Triathlon Tibial Alignment Ankle Clamp EM

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

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
    17924
  • Event Initiated Date
    2015-02-27
  • 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 orthopaedics carried out a recall for product correction in july 2013 due to complaints associated with cracks or fracture of the plastic triathlon tibial alignment ankle clamp (old design). this issue may lead to potential complications during surgery in the event a replacement sterile ankle clamp is required mid-procedure, which may create a delay exceeding 30 minutes in duration. stryker will organise the swap out of any old plastic clamps for the new metal clamps.
  • Action
    Product to be exchanged

Device

Stryker Triathlon Tibial Alignment Ankle Clamp EM
  • Model / Serial
    Model: Catalogue Number: 65412609. Affected Kits: 65418002-T, 65418030-T, TRIAR36PREP-T, WKSHP65418002-T & SHAPECONV-T, Affected: Lot Numbers: Lots prior to X9L06
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

Stryker Howmedica Osteonics
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA