Events

Retiro De Equipo (Recall) de Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm (non-biodegradeable orthopaedic bone screw)

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-00646-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-17
  • 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-00646-1
  • 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 packaging for item 400.688s (cortex screw ø 1.3 mm, self-tapping, length 8 mm, sterile) was found to contain product 400.808s (cortex screw ø 1.5 mm, self-tapping, length 8 mm, sterile). the presence of a screw that is 1.5mm in diameter instead of 1.3mm (or 1.3mm vs 1.5mm) may cause surgical delay if the surgeon may specifically require a 1.3 or 1.5mm due to the patient's impacted anatomical structure.
  • Acción
    Customers are requested to isolate Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm from the affected lot for return to DePuy Synthes.

Device

Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm (non-biodegradeable orthopaedic bone screw)
  • Modelo / Serial
    Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm (non-biodegradeable orthopaedic bone screw)Part Number: 400.808 Lot Number: 2798707 ARTG Number: 157068
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd