Events

Retiro De Equipo (Recall) de A-642100 fixed offset adaptor (used in external 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 Ossur Asia-Pacific.

¿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-01236-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-21
  • 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-01236-1
  • 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 manufacturer has received reports of the affected devices developing fatigue cracks in normal use over an extended period of time and may ultimately separate. since there is hardly any visible or audible sign indicating potential breakage, ossur strongly recommends the retrieval of all components in the field. no injuries resulting from such a failure have been reported and this is a precautionary step.This recall action was carried out prior to the approval of the recall strategy by the tga.
  • Acción
    Ossur is recommending patients have the affected component replaced with a different component, and return any remaining inventory to Ossur.

Device

A-642100 fixed offset adaptor (used in external prosthesis)
  • Modelo / Serial
    A-642100 fixed offset adaptor (used in external prosthesis)All units sold since 1 January 2008
  • Manufacturer
    Ossur Asia-Pacific

Manufacturer

Ossur Asia-Pacific
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    DHTGA