Events

Recall of Stryker Accolade TMZF Hip Stem

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
    13738
  • Event Initiated Date
    2012-11-01
  • 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
    The manufacturer advises that size 3..5 stems 3.5 stems may be labelled and size 2.5 stems and vice versa., this applies to specific lots of stems however only one affected product (lot) was ever used and implanted in new zealand : a 2.5 stem .Therefore, this could potentially have had a 3.5 stem inside.
  • Action
    Manufacturer to issue advice regarding use

Device

Stryker Accolade TMZF Hip Stem

Manufacturer

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