Events

Retiro De Equipo (Recall) de ALTRUS THERMAL TISSUE FUSION SYSTEM - HANDPIECE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CONMED CANADA.

¿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
    138943
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-10-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Conmed corporation confirmed that two lots of altrus thermal tissue fusion handpiece devices were exposed to a higher than acceptable level of particulate matter during manufacture in march 2013. device sterility and performance are unaffected by this exposure. these lots were released for distribution without following the specific documentation requirements of conmed electrosurgery to place the affected products on non-conformance report prior to disposition. in october 2013 conmed notified the usfda of their intent to recall altrus thermal tissue fusion handpieces catalog no. 60-9520-001 lot 13chb007 and 60-9522-001 lot 13chb006 due to exposure to high particle count during manufacture. only catalog no. 60-9522-001 lot 13chb006 was distributed in canada.

Device

ALTRUS THERMAL TISSUE FUSION SYSTEM - HANDPIECE
  • Modelo / Serial
    Model Catalog: 60-9522-001 (Lot serial: 13CHB006)
  • Descripción del producto
    ALTRUS Thermal Tissue Fusion Handpieces
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    HC