Events

Recall of Coloplast Restorelle

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Coloplast A/S.

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
    19111
  • Event Initiated Date
    2015-09-22
  • 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: Culpan Distributors Ltd, Unit 10, 19 Hannigan Drive, Mt Wellington, Auckland
  • Reason
    Following a tga review, coloplast pty ltd has made significant and substantive updates to the instructions for use (ifu) for the referenced products. additional contraindications, warnings, and precautions have been added to present the most comprehensive and up to date information available., the key messages include the importance of:, - appropriate patient selection;, - surgeon experience; and, - the need for fully informed patient consent.
  • Action
    Instructions for use to be updated

Device

Coloplast Restorelle
  • Model / Serial
    Model: All models, Affected: All lots
  • Manufacturer
    Coloplast A/S

Manufacturer

Coloplast A/S