Events

Retiro De Equipo (Recall) de Small Pedicle Probe ELL-IN 02 23-N

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Spineart 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-2018-RN-00087-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-07
  • 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-2018-RN-00087-1
  • 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
    Spineart australia has been made aware that there is a non conformance on the graduation of the device. the graduation is 30/40/45/60 mm instead of 30/40/50/60 mm. investigation from the sponsor has determined that this engraving error comes from the etching step during manufacturing and had not been caught duing the manufacturers control step. no other batches of the same reference are affected by this issue.There have been no reported events as a reuslt of this issue.This action was undertaken prior to consultation with the therapeutic goods adminsitration (tga).
  • Acción
    The affected item has been quarantined and returned to the manufacturer.

Device

Small Pedicle Probe ELL-IN 02 23-N
  • Modelo / Serial
    Small Pedicle Probe ELL-IN 02 23-NModel Reference Number: ELL-IN 02 23-NBatch Number: 3-8213ARTG Number: 228975
  • Manufacturer
    Spineart Australia Pty Ltd

Manufacturer

Spineart Australia Pty Ltd