Events

Retiro De Equipo (Recall) de Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when used in conjunction with Offset Tibial Tray

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Exactech 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-2017-RN-01273-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-07
  • 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-2017-RN-01273-1
  • 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
    Exactech initiated a corrective action for the affected catalogue numbers due to a design incompatibility between the optetrak offset spine stiffener screw and the optetrak constrained condylar (cc) tibial insert when used in conjunction with an optetrak offset tibial tray. the optetrak offset spine stiffener screw is offered in a variety of sizes and is used as a secondary means to secure the optetrak constrained condylar (cc) tibial insert to the optetrak offset tibial tray. in all but one combination, the next size optetrak offset spine stiffener screw can be used without any anticipated adverse health consequences. exactech anticipates there may be a slight surgical delay while a larger screw is opened.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Acción
    Exactech has provided users with an updated compatibility chart.

Device

Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when...
  • Modelo / Serial
    Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when used in conjunction with Offset Tibial TrayMultiple Catalogue Numbers and ProductsAll serial numbers affectedARTG Number: 252474
  • Manufacturer
    Exactech Australia Pty Ltd

Manufacturer

Exactech Australia Pty Ltd