Events

Recall of Cochlear Soft Tissue Gauge

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Cochlear Bone Anchored Solutions AB.

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
    16554
  • Event Initiated Date
    2014-04-17
  • 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: Cochlear NZ Limited, C/- KPMG, 18 Viaduct Harbour Ave, Auckland 1010
  • Reason
    Manufacturer informed of a potential quality issue with the product. a health risk assessment was performed and the following potential risks were identified:, 1. metal fragement comes loose and ends up on/ under the patient's skin during surgery casuing an inflammatory response, 2. endotocins lefton instrument after cleaning and sterilisation, 3.Metal fragment/ sharp edge (causing additional scratches to soft tissue during surgery.).
  • Action
    Product to be destroyed

Device

Cochlear Soft Tissue Gauge

Manufacturer

Cochlear Bone Anchored Solutions AB