Events

Retiro De Equipo (Recall) de 3R62 Pheon Modular Knee Joint (External leg prosthesis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Otto Bock 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-01512-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-11-22
  • 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-01512-1
  • 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
    It has been found that the locking function may fail under certain conditions. the activation locking can only be activated by the clinician prior to the fitting of the device. the units that have been supplied in australia do not have the locking mechanism activated. please note that when the locking mechanism is set as non-active, the device poses no safety risk to the patient. however, it is possible that in the course of time the patient’s physical condition may require the locking function to be activated.
  • Acción
    Otto Back is advising clinicians to contact patients who have been fitted with the affected device for a replacement with the new version.

Device

3R62 Pheon Modular Knee Joint (External leg prosthesis)
  • Modelo / Serial
    3R62 Pheon Modular Knee Joint (External leg prosthesis)Serial Numbers: 201447012, 201512056, 201517011ARTG Number: 113606
  • Manufacturer
    Otto Bock Australia Pty Ltd

Manufacturer

Otto Bock Australia Pty Ltd