Events

Retiro De Equipo (Recall) de Silane (dentine adhesive)

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-2014-RN-01241-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-21
  • 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-2014-RN-01241-1
  • 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
    Kerr australia pty ltd has identified that the instructions for use (ifus) incorrectly state, “silane is intended to be used as a coupler between the prepared tooth and the cement on the restoration.” the correct indication is, “silane is intended to be used as a coupler between the cement and porcelain restoration.” please be aware that the incorrect indication in the ifu may lead to the possibility of decrease in bond strength and sensitivity.
  • Acción
    Customers are requested to immediately return any affected units to Kerr Australia. Returned stock will be replaced at no cost. This action has been closed-out on 01/03/2016.

Device

Silane (dentine adhesive)
  • Modelo / Serial
    Silane (dentine adhesive)Part number: NO4EALot numbers: 3538939, 3572479, 3601537, 3611227, 3264640, 3657461, 3666325, 4387029, 4424253, 4424254, 4485709, 4492806, 4568212, 4618485, 4653026, 4653027, 4653028, 4761586, 4792641, 4824305, 4862783, 4909767, 4947563, 4949092, 5034160, 5085067, 5155175, 5173162, 5204585, 5224590 & 5286924ARTG number: 175796
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd