Events

Retiro De Equipo (Recall) de Abutment Retrieval Instrument Zirconia CC RP/WP This instrument can be included in Abutment Retrieval Kit.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Nobel Biocare 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-2015-RN-00572-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-06-26
  • 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-2015-RN-00572-1
  • 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
    An internal investigation by the manufacturer showed that one dimension of the affected instrument is incorrect. therefore this instrument cannot be used to remove the metal adapter as intended.
  • Acción
    Nobel Biocare is requesting their customers to cease using the device and to return it to a Nobel Biocare subsidiary and receive a replacement instrument. If the affected instrument is a part of a kit, a Nobel Biocare Representative will contact the customer directly. This action has been closed-out on 03/03/2016.

Device

Abutment Retrieval Instrument Zirconia CC RP/WP This instrument can be included in Abutment Retri...
  • Modelo / Serial
    Abutment Retrieval Instrument Zirconia CC RP/WP Reference# 37882Batch# 96149 This instrument can be included in Abutment Retrieval Kit, Reference 37508, batches 814929, 815096, 815140, and 855021.
  • Manufacturer
    Nobel Biocare Australia Pty Ltd

Manufacturer

Nobel Biocare Australia Pty Ltd