Events

Retiro De Equipo (Recall) de Multiple Polishing Products containing Optrapol (a dental polishing system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ivoclar Vivadent 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-2016-RN-00906-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-27
  • 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-2016-RN-00906-1
  • 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
    As a precautionary measure, ivoclar vivadent is recalling certain products. the affected polisher may suffer increased wear during use.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Acción
    Ivoclar Vivadent advised users to check stock and return the affected product for credit. This action has been closed-out on 20/11/2017.

Device

Multiple Polishing Products containing Optrapol (a dental polishing system)
  • Modelo / Serial
    Multiple Polishing Products containing Optrapol (a dental polishing system)Products affected: OptraPol Small Flame, OptraPol PromoPack, OptraPol TestPack, OptraPol Assortment, OptraPol Cuo Refill, Tetric N-Ceram System Kit A2/N Uv.6g, Telio CS C&B; Starter Kit A2, Direct Restoratives Workshop Kit, Composite Workshop Kit (Emp. Bulk Fill)Multiple Article and Lot Numbers affectedARTG Number: 106523
  • Manufacturer
    Ivoclar Vivadent Pty Ltd

Manufacturer

Ivoclar Vivadent Pty Ltd