Events

Rappel de Cochlear Soft Tissue Gauge

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Cochlear Bone Anchored Solutions AB.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    16554
  • Date de mise en oeuvre de l'événement
    2014-04-17
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Cochlear NZ Limited, C/- KPMG, 18 Viaduct Harbour Ave, Auckland 1010
  • Cause
    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