Events

Rappel de Tytin Regular Set (Dental amalgam) Tytin Regular Set, Double Spill - 50 Capsules

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-00606-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-03
  • 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-00606-1
  • 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 manufacturer, kerr corporation has received complaints that the amalgam may set faster than specified in the directions for use. this set time discrepancy may cause the product to set before there is an opportunity to place it in the preparation or to complete the carving process. there is a low risk associated with the use of this product in that there would be a possible need to remove the set amalgam from the preparation and repeat the procedure.
  • Action
    Customers are advised to immediately return any of the affected stock to Kerr Australia for replacement with unaffected stock.

Device

Tytin Regular Set (Dental amalgam) Tytin Regular Set, Double Spill - 50 Capsules
  • Modèle / numéro de série
    Tytin Regular Set (Dental amalgam)Tytin Regular Set, Double Spill - 50 CapsulesPart number: 29948Lot number: 3-1249ARTG Number: 99936
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd