Events

Rappel de Maxcem Elite (Dental cement)

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-2013-RN-00198-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-03-04
  • 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-2013-RN-00198-1
  • 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
    It has come to the attention of kerr australia that an issue with the raw material used to produce the affected lots of maxcem elite causes the material to prematurely polymerise in the syringe. the product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to replacing restorations on the tooth or core build up. as a result, the restoration may not be sealed properly.
  • Action
    Kerr Australia is requesting customers to review their stock and to determine if they have any affected lots. Any affected lots have been requested to be returned to Kerr Australia immediately.

Device

Maxcem Elite (Dental cement)
  • Modèle / numéro de série
    Maxcem Elite (Dental cement)Multiple part numbers and lot numbersProduct with expiration dates through August 2015ARTG Number: 175450
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd