Events

Recall of Atrium C-QUR TacShield

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

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
    15034
  • Event Initiated Date
    2013-07-25
  • 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: Atrium NZ Limited, 9 Cambourne Street, Sandringham, Auckland
  • Reason
    The coated meshes can adhere to the inner packaging liner. when removing the c-qur mesh from the liner, pieces of the coating of the mesh can be left behind on the packaging liner.
  • Action
    Instructions for use to be updated

Device

Atrium C-QUR TacShield
  • Model / Serial
    Model: 31610, 31611, 31612, 31626, 31628, 3163, 31636, 31637, 31638 and 21644, Affected:
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA