Events

Retiro De Equipo (Recall) de INSERTER FOR TITANIUM ELASTIC NAILS

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
    59424
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-02-23
  • 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. received notification from its supplier synthes (usa) that a determination had been made that a voluntary recall would be performed as it was reported the inserter for titanium elastic nails (ten) has the potential for mechanical failures such as breakage of the main shaft of the inserter for the ten malfunction of the chuck of the inserter for the ten in the form of the chuck getting stuck/jammed breakage of the cross bar of the inserter for the ten as a result of hammering and failure of the back end of the inserter by loosening and falling off.

Device

INSERTER FOR TITANIUM ELASTIC NAILS
  • Modelo / Serial
    Model Catalog: 359.219 (Lot serial: > 10 numbers contact mfg)
  • Descripción del producto
    INSERTER FOR TITANIUM ELASTIC NAILS
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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