Events

Rappel de Silane (dentine adhesive)

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-2014-RN-01241-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-21
  • 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-2014-RN-01241-1
  • 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 pty ltd has identified that the instructions for use (ifus) incorrectly state, “silane is intended to be used as a coupler between the prepared tooth and the cement on the restoration.” the correct indication is, “silane is intended to be used as a coupler between the cement and porcelain restoration.” please be aware that the incorrect indication in the ifu may lead to the possibility of decrease in bond strength and sensitivity.
  • Action
    Customers are requested to immediately return any affected units to Kerr Australia. Returned stock will be replaced at no cost. This action has been closed-out on 01/03/2016.

Device

Silane (dentine adhesive)
  • Modèle / numéro de série
    Silane (dentine adhesive)Part number: NO4EALot numbers: 3538939, 3572479, 3601537, 3611227, 3264640, 3657461, 3666325, 4387029, 4424253, 4424254, 4485709, 4492806, 4568212, 4618485, 4653026, 4653027, 4653028, 4761586, 4792641, 4824305, 4862783, 4909767, 4947563, 4949092, 5034160, 5085067, 5155175, 5173162, 5204585, 5224590 & 5286924ARTG number: 175796
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd