Events

Retiro De Equipo (Recall) de SCHANZ SCREW

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SYNTHES (CANADA) 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
    129484
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-04-14
  • 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
    Labelling changes have been made to synthes external fixation systems (small medium and large) related to magnetic resonance (mr) conditions as a result of changes in required testing protocols/standard to designate a product mr safe mr conditional and mr unsafe. metal devices are no longer identified as mr safe and as a result synthes external fixation systems are no longer labelled mr safe. the synthes external fixation systems are now identified as mr conditional.

Device

SCHANZ SCREW
  • Modelo / Serial
    Model Catalog: 294.55 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.783 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.782 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.779 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.774 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.773 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.772 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.771 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.778 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.777 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.776 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.775 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.775SHA (Lot serial: >10 numbers contact mfg); Model Catalog: 294.776SHA (Lot serial: >10 numbers contact mfg); Model Catalog: 294.777SHA (Lot serial: >10 numbers contact mfg); Model Catalog: 294.779SHA (Lot serial: >10 numbers contact mfg); Model Catalog: 294.7
  • Descripción del producto
    SCHANZ SCREW
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC