Events

Retiro De Equipo (Recall) de Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Preci-Clip

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Alphabond Dental 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-00621-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-15
  • 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-00621-1
  • 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
    The product recall is implemented by the manufacturer, alphadent nv as a result of the cancellation of the company's ce certificate of conformity. alphadent nv has not received any injury reports relating either directly or indirectly to the medical devices (ceka attachments) subject to this recall. however, as a precautionary measure and in order to ensure compliance with applicable legislative requirements, alphadent nv has decided to initiate a recall of the concerned medical devices manufactured from 13 september 2013 with batch number 13091 and subsequent batches.
  • Acción
    Alphadent is advising users to inspect stock and quarantine any remaining stock for return or credit.

Device

Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Pre...
  • Modelo / Serial
    Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Preci-ClipBatch Number: 13091 and subsequent Manufactured from 13 September 2013ARTG Number: 108721
  • Manufacturer
    Alphabond Dental Pty Ltd

Manufacturer

Alphabond Dental Pty Ltd