Events

Rappel de Sealapex Xpress(calcium hydroxide polymeric root canal sealant)

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-2017-RN-00314-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-07
  • 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-2017-RN-00314-1
  • 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
    A labelling error has been identified with a single lot of sealapex xpress. the product’s syringe label correctly identifies the expiration date as 2016-11. some carton labels incorrectly identify the expiration date as 2017-11. product used past the correct expiration date of 2016-11 may not perform as intended. such product may exhibit crystals in the catalyst paste.
  • Action
    Kerr Endodontics is requesting distributors to identify customers with affected stock and to forward the customer letter to inform them of the issue. Customers with affected stock are requested to contact SybronEndo Customer Care in order to receive a RMA number to facilitate the return and replacement or credit of their affected products.

Device

Sealapex Xpress(calcium hydroxide polymeric root canal sealant)
  • Modèle / numéro de série
    Sealapex Xpress(calcium hydroxide polymeric root canal sealant)Part Number: 33639Lot Number: 5-1310ARTG Number: 236668
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd