Events

Rappel de Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental restoration)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Kerr 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-2016-RN-00770-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-06-08
  • 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-00770-1
  • 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
    Kerr australia is recalling certain lots of herculite ultra, herculite xrv, point 4, and premise, where an issue with the production process used to package the affected lots may lead to the presence of plastic particulates in the dental composite material. the particulate is visible to doctors and should be easy to remove prior to or even after curing. the particulate is unlikely to cause any adverse health consequences.
  • Action
    Kerr Australia is advising users that there is no need to replace any restorations placed with this material. Any remaining stocks of the affected product should be returned to Kerr.

Device

Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental restoration)
  • Modèle / numéro de série
    Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental restoration)Multiple Lot Numbers and Part Numbers affectedShipped between June 2015 and April 2016ARTG Number: 99818
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd