Retiro De Equipo (Recall) de 3M ESPE Lava Ultimate CAD/CAM Restorative (Dental mill block)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por 3M 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Approximately 10% of users globally have reported to 3m that lava ultimate crowns de-bonded at a rate higher than their typical experience for crowns. the reported de-bond rates varied greatly and often significantly exceeded the 2-4% rates generally reported in clinical literature. based on customer feedback, the product is not meeting performance expectations for consistent and predictable outcomes for the crown indication.
  • Acción
    3M is notifying dentists of the issue and providing the Instructions for Use. Wholesalers are requested to return any remaining stock. This action has been closed-out on 20/06/2016.


  • Modelo / Serial
    3M ESPE Lava Ultimate CAD/CAM Restorative (Dental mill block)ARTG Number: 191737
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source