Events

Retiro De Equipo (Recall) de Airlight ROM brace (An Orthosis that encompases the knee joint)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Australian Orthotic Technologies 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-00090-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-30
  • 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-00090-1
  • 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
    Australian orthotic technologies received notification of failures on a small number of the ossur rehab universal airlight range of motion knee braces code b-222000000; whereby the braces have broken at the hinge. customers returned a small quantity (7%) of these braces that had failed under the same circumstance (locking hinge mechanism breakage) suggesting that there may be a potentially faulty batch. the manufacturer was advised of the issue and affected batch removed from stock.This action was initiated prior to consultation with the therapeutic goods administration.
  • Acción
    Australian Orthotic Technologies advised the customers of the locking hinge mechanism failure along with the instructions of how to test product integrity. ATO sales representative visited the customers and completed a swap out of affected batch to new batch. This action was undertaken prior to consultation with the Therapeutic Goods Administration.

Device

Airlight ROM brace (An Orthosis that encompases the knee joint)
  • Modelo / Serial
    Airlight ROM brace (An Orthosis that encompases the knee joint)Product Code: B-222000000 Batch Number: 091013Lot Number: 130827 ARTG Number: 135047
  • Manufacturer
    Australian Orthotic Technologies Pty Ltd

Manufacturer

Australian Orthotic Technologies Pty Ltd
  • Source
    DHTGA