Events

Retiro De Equipo (Recall) de Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental restoration)

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-2016-RN-00770-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-06-08
  • 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-00770-1
  • 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 is recalling certain lots of herculite ultra, herculite xrv, point 4, and premise, where an issue with the production process used to package the affected lots may lead to the presence of plastic particulates in the dental composite material. the particulate is visible to doctors and should be easy to remove prior to or even after curing. the particulate is unlikely to cause any adverse health consequences.
  • Acción
    Kerr Australia is advising users that there is no need to replace any restorations placed with this material. Any remaining stocks of the affected product should be returned to Kerr.

Device

Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental restoration)
  • Modelo / Serial
    Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental restoration)Multiple Lot Numbers and Part Numbers affectedShipped between June 2015 and April 2016ARTG Number: 99818
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd