Retiro De Equipo (Recall) de SALVIN FIXATION SCREWS

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

¿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
    120809
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-07-15
  • País del evento
  • 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
    As the result of a medical device inspection conducted by health canada which was completed on september 2013 salvin dental discovered that the mentioned products are devices sold without canadian licences in contravention of the medical device regulations in canada.

Device

  • Modelo / Serial
    Model Catalog: FIX-1.5*10-PT (Lot serial: na); Model Catalog: TACK-5-PT (Lot serial: na); Model Catalog: TACK-3-PT (Lot serial: na); Model Catalog: FIX-1.5*13-PT (Lot serial: na); Model Catalog: FIX-1.5*13PT (Lot serial: na); Model Catalog: FIX-2.0*13-PT (Lot serial: na); Model Catalog: FIX-2.0*8-PT (Lot serial: na); Model Catalog: FIX-2.0*6-PT (Lot serial: na); Model Catalog: FIX-2.0*4-PT (Lot serial: na); Model Catalog: FIX-2.0*17-PT (Lot serial: na); Model Catalog: FIX-2.0*15-PT (Lot serial: na); Model Catalog: FIX-2.0*10-PT (Lot serial: na); Model Catalog: FIX-1.5*8-PT (Lot serial: na); Model Catalog: FIX-1.5*6-PT (Lot serial: na); Model Catalog: FIX-1.5*4-PT (Lot serial: na); Model Catalog: FIX-1.5*17-PT (Lot serial: na); Model Catalog: FIX-1.5*15-PT (Lot serial: na)
  • Descripción del producto
    SALVIN FIXATION SCREWS;SALVIN TACKS
  • Manufacturer

Manufacturer