Events

Retiro De Equipo (Recall) de Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Tornier 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-00973-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-20
  • 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-00973-1
  • 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
    Tornier sas has identified that some reversed cut guides have been incorrectly assembled during the manufacturing process. a faulty guide will generate an incorrect version measurement and may cause confusion or an improper humeral head resection. all the parts affected come from the same lot number (dp0213287).
  • Acción
    Tornier Pty Ltd have all the affected products within their warehouses or their distributors warehouses. Tornier is checking the stock or requesting the distributors to check the stock and if faulty guides are identified, will replace the faulty guides with new ones. This action was undertaken prior to consultation with the Therapeutic Goods Administration.

Device

Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses)
  • Modelo / Serial
    Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses)Item Number: MWF011Lot Number: DP0213287ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd