Events

Retiro De Equipo (Recall) de QUADRA C-CEMENTED STANDARD MIRROR POLISHED STEM 12/14

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDACTA 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
    150423
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-03-05
  • 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
    The manufacturer has determined that after a fracture of a stem neck due to scratches made by the surgeon during femoral head revision. medacta international sa has decided to modify the ifu of its hip implants adding the following sentence. "the operating surgeon has to be aware that a scratched neck can have influence to the endurance of the stem and can lead to an early fracture of the stem neck.".

Device

QUADRA C-CEMENTED STANDARD MIRROR POLISHED STEM 12/14
  • Modelo / Serial
    Model Catalog: 01.12.047 (Lot serial: ALL); Model Catalog: 01.18.158 (Lot serial: All); Model Catalog: 01.12.045 (Lot serial: ALL); Model Catalog: 01.12.044 (Lot serial: ALL); Model Catalog: 01.12.043 (Lot serial: ALL); Model Catalog: 01.12.042 (Lot serial: ALL); Model Catalog: 01.12.041 (Lot serial: ALL); Model Catalog: 01.12.040 (Lot serial: ALL); Model Catalog: 01.18.150 (Lot serial: All); Model Catalog: 01.18.151 (Lot serial: All); Model Catalog: 01.18.152 (Lot serial: All); Model Catalog: 01.18.153 (Lot serial: All); Model Catalog: 01.18.154 (Lot serial: All); Model Catalog: 01.18.155 (Lot serial: All); Model Catalog: 01.18.156 (Lot serial: All); Model Catalog: 01.18.157 (Lot serial: All); Model Catalog: 01.12.046 (Lot serial: ALL)
  • Descripción del producto
    QUADRA C-CEMENTED STANDARD MIRROR POLISHED STEM 12/14
  • Manufacturer
    MEDACTA CANADA

Manufacturer

MEDACTA CANADA
  • Dirección del fabricante
    KITCHENER
  • Empresa matriz del fabricante (2017)
    Medacta Holding Sa
  • Source
    HC