Events

Retiro De Equipo (Recall) de Anspach Attachments and Handpieces (reusable surgical devices)

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-00651-1
  • 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-00651-1
  • 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
    Internal testing of sterrad® 100s sterilisation process has shown that several anspach attachments and handpieces did not achieve the expected sterility assurance level (sal) of 10-6.
  • Acción
    Synthes Australia is notifying their customers of the removal of the recommendation to sterilise Anspach Attachments and Handpieces in the STERRAD 100S (Hydrogen Peroxide Gas Plasma Technology). Steam sterilisation method is still validated for the sterilisation of these devices.

Device

Anspach Attachments and Handpieces (reusable surgical devices)
  • Modelo / Serial
    Anspach Attachments and Handpieces (reusable surgical devices)Multiple part numbers and lot numbersARTG Numbers: 141597, 141559, 141600, 146267 and 155913
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd