Events

Retiro De Equipo (Recall) de T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System)

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-00852-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-07-31
  • 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-00852-1
  • 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 manufacturer’s assessment has identified that incorrect handling of the t-pal applicator instrument could potentially contribute to failure of the applicator inner shaft (pn 03.812.003) during insertion of implants or the non-detachable t-pal trial implants (pn 03.812.307-.317 and 03.812.507-517). as a result, the t-pal technique guide (pn 036.001.088) was updated to clarify instrument handling of the t-pal applicator (pn 03.812.001 applicator outer shaft, pn 03.812.004 applicator knob). if the inner shaft should break, the trial (or implant) spacer will no longer be secured in the 0° position. this rigid position is necessary for insertion. if the inner shaft should break in the pivoting position, the assembly cannot be properly advanced into the disc space.
  • Acción
    Synthes Australia is requesting their customers to replace the T-PAL Technique Guide with the updated version (PN 036.001.088, Version AD). This action has been closed-out on 03/06/2016.

Device

T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System)
  • Modelo / Serial
    T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System) ARTG number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd