Events

Rappel de Neoss Guide – Drill-Hubs I to V included in Neoss

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Neoss Australia Pty 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
    RC-2015-RN-00917-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00917-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    These 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.No incidents have been reported in australia.
  • Action
    Customers are asked to inspect their stock on hand and to quarantine affected units prior to their return to Neoss as per the instructions in the Customer Letter.

Device

Neoss Guide – Drill-Hubs I to V included in Neoss
  • Modèle / numéro de série
    Neoss Guide – Drill-Hubs I to V included in NeossGuide Kit Ø3.5 - Ø4.5 (art no 51153) Identifier #9040Batch Number: 15182, 15586, 16030ARTG Number: 119446
  • Manufacturer
    Neoss Australia Pty Ltd

Manufacturer

Neoss Australia Pty Ltd