Events

Rappel de Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Preci-Clip

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Alphabond Dental 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-2016-RN-00621-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-15
  • 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-2016-RN-00621-1
  • 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
    The product recall is implemented by the manufacturer, alphadent nv as a result of the cancellation of the company's ce certificate of conformity. alphadent nv has not received any injury reports relating either directly or indirectly to the medical devices (ceka attachments) subject to this recall. however, as a precautionary measure and in order to ensure compliance with applicable legislative requirements, alphadent nv has decided to initiate a recall of the concerned medical devices manufactured from 13 september 2013 with batch number 13091 and subsequent batches.
  • Action
    Alphadent is advising users to inspect stock and quarantine any remaining stock for return or credit.

Device

Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Pre...
  • Modèle / numéro de série
    Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Preci-ClipBatch Number: 13091 and subsequent Manufactured from 13 September 2013ARTG Number: 108721
  • Manufacturer
    Alphabond Dental Pty Ltd

Manufacturer

Alphabond Dental Pty Ltd