Events

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

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Kerr Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00983-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-18
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00983-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / Serial
    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