Events

Retiro De Equipo (Recall) de FLEXIBLE MEDULLARY REAMER

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
    110565
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-06-12
  • 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
    Synthes (canada) ltd. is initiating a voluntary recall to remove the affected flexible meduallary reamer. this recall is being initiated as the coiled design for this product is difficult to clean and the potential for corrosion on the device exists. the potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned. synthes has not received any reports of adverse events associated with the use of the flexible medullary reamer.

Device

FLEXIBLE MEDULLARY REAMER
  • Modelo / Serial
    Model Catalog: 359.115 (Lot serial: ALL LOTS); Model Catalog: 359.106 (Lot serial: ALL LOTS)
  • Descripción del producto
    FLEXIBLE MEDULLARY REAMER
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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