Events

Rappel de 3M ESPE Lava Ultimate CAD/CAM Restorative (Dental mill block)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par 3M 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-00551-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-23
  • 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-00551-1
  • 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
    Approximately 10% of users globally have reported to 3m that lava ultimate crowns de-bonded at a rate higher than their typical experience for crowns. the reported de-bond rates varied greatly and often significantly exceeded the 2-4% rates generally reported in clinical literature. based on customer feedback, the product is not meeting performance expectations for consistent and predictable outcomes for the crown indication.
  • Action
    3M is notifying dentists of the issue and providing the Instructions for Use. Wholesalers are requested to return any remaining stock. This action has been closed-out on 20/06/2016.

Device

3M ESPE Lava Ultimate CAD/CAM Restorative (Dental mill block)
  • Modèle / numéro de série
    3M ESPE Lava Ultimate CAD/CAM Restorative (Dental mill block)ARTG Number: 191737
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Société-mère du fabricant (2017)
    3m Company
  • Source
    DHTGA