Events

Retiro De Equipo (Recall) de Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal coupling

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Synthes 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-2014-RN-00354-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-24
  • 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-2014-RN-00354-1
  • 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 for this particular lot (3632704) was distributed with "not for human use" etched on the side of the tool. the etching was intended to indicate that the devices were for training purposes only. if the "not for human use" etching on the threaded reduction tool is discovered prior to its use on the patient, but in the operative theatre, it could lead to a small surgical delay until a replacement product is procured.Synthes has advised that if the product was used in an operation, the threaded reduction tool would work as intended and the patient would not be exposed to any increased risk.
  • Acción
    End users are requested to immediately isolate any devices from the affected lot. Affected devices are to be returned to Synthes Australia.

Device

Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal coupling
  • Modelo / Serial
    Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal couplingPart Number: 03.507.002SLot Number: 3632704ARTG Number: 155807
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd