Events

Retiro De Equipo (Recall) de Mini RPE Screw Assembly (Orthodontic Appliance System)Mandibular Anterior Repositioning Appliance (M.A.R.A.)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ormco 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-00614-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-25
  • 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-00614-1
  • 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
    Ormco has become aware that the rpe screw assembly in palate expander devices is missing a complete weld joining one side of the arm with the screw body. only a single device potentially affected by this issue is in use.
  • Acción
    Ormco are asking their customer to inspect the patient's device at their next appointment. If an incomplete weld is identified, the orthodontist is required to either continue to monitor the patient during the time the palate expander treatment or remove the device and return to Ormco for replacement,

Device

Mini RPE Screw Assembly (Orthodontic Appliance System)Mandibular Anterior Repositioning Appliance...
  • Modelo / Serial
    Mini RPE Screw Assembly (Orthodontic Appliance System)Mandibular Anterior Repositioning Appliance (M.A.R.A.)Part number: 3000-0012All Devices manufactured from 3 April 2013 to 21 May 2013.ARTG Number: 110055
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd