Events

Rappel de Neoss Guide - Drill hubs I to V included in Neoss Guide Kit

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 Neoss Ltd.

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
    19204
  • Date de mise en oeuvre de l'événement
    2015-09-29
  • 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: Neoss Australia Pty Ltd (NZ), 61 Penney Ave, Mt Roskill, Auckland 1041
  • Cause
    Specific batches of drill-hub i may not be functioning as intended (drill does not latch completely in the drill-hub i)., the upper part of the bore in the drill-hub i is slightly smaller which results in the drill not being seated correctly which means that this drill-hub will drill deeper than intended. this could lead to permanent damage of the alveolar nerve and cause permanent loss of sense in parts of the oral cavity or chin or even partial loss of speech. there is also a risk of drill loosening or not rotating as expected.
  • Action
    Product to be returned to supplier

Device

Neoss Guide - Drill hubs I to V included in Neoss Guide Kit
  • Modèle / numéro de série
    Model: 51153, Affected: 15182, 15586, 16030
  • Manufacturer
    Neoss Ltd

Manufacturer

Neoss Ltd
  • Société-mère du fabricant (2017)
    Neoss Ltd.
  • Source
    NZMMDSA