Events

Retiro De Equipo (Recall) de Maxcem Elite (Dental cement)

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-00198-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-03-04
  • 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-00198-1
  • 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
    It has come to the attention of kerr australia that an issue with the raw material used to produce the affected lots of maxcem elite causes the material to prematurely polymerise in the syringe. the product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to replacing restorations on the tooth or core build up. as a result, the restoration may not be sealed properly.
  • Acción
    Kerr Australia is requesting customers to review their stock and to determine if they have any affected lots. Any affected lots have been requested to be returned to Kerr Australia immediately.

Device

Maxcem Elite (Dental cement)
  • Modelo / Serial
    Maxcem Elite (Dental cement)Multiple part numbers and lot numbersProduct with expiration dates through August 2015ARTG Number: 175450
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd