Events

Rappel de NX3 Try-In Gel Syringe Refills, Bleach (dental material used to preview the expected shade of a tooth restoration before final cementation)

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-00983-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-18
  • 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-00983-1
  • 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
    Nx3 try-in gels allow for the restorations to be seated temporarily for review of their final appearance prior to cementation. kerr australia have received reports that some nx3 try-in gel syringes in the affected lot incorrectly contain a polishing paste. as the material in the affected syringe does not match the shade of the cement as it is labeled there is a risk that use of the affected material to evaluate shade prior to cementation may result in an unanticipated final restoration colour requiring the need to remove and repeat the restoration.
  • Action
    Kerr Australia is requesting customers to stop using the affected product and return to Kerr Australia for replacement or credit.

Device

NX3 Try-In Gel Syringe Refills, Bleach (dental material used to preview the expected shade of a t...
  • Modèle / numéro de série
    NX3 Try-In Gel Syringe Refills, Bleach (dental material used to preview the expected shade of a tooth restoration before final cementation)Part Number: 33660Syringe Lot Number: 4580333Autobag Lot Number: 4584609Expiry date: February 2014ARTG Number: 176398
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd