Events

Recall of William Cook Europe Zenith Alpha™ Thoracic Endovascular Graft (ZTA-/-)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by William Cook Europe ApS.

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
    23283
  • Event Initiated Date
    2018-07-03
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    The manufacturer is notifing customers of the changes to the ifu consising of an editorial revision made to ensure clarity and ease of use of the zenith alpha™ thoracic endovascular graft. the update of the ifu is not initiated based on a safety issue.
  • Action
    Instructions for use to be updated

Device

William Cook Europe Zenith Alpha™ Thoracic Endovascular Graft (ZTA-/-)
  • Model / Serial
    Model: , Affected: Zenith Alpha™ Thoracic Endovascular Graft.
  • Manufacturer
    William Cook Europe ApS

Manufacturer

William Cook Europe ApS