Events

Retiro De Equipo (Recall) de GRAPHIC CASES FOR 6.5MM & 7.3MM CANNULATED SCREW SETS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    94209
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2018-03-08
  • 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
    Depuy synthes is conducting a lot-specific recall of the graphic cases for 6.5mm and 7.3mm cannulated screw sets because they contain screw gauges that incorrectly measure screws 5.41mm shorter than the actual overall screw length. thus when using the measuring gauge the surgeon would potentially be inserting a screw which is 5.41mm shorter than intended.

Device

GRAPHIC CASES FOR 6.5MM & 7.3MM CANNULATED SCREW SETS
  • Modelo / Serial
    Model Catalog: 690.379-US (Lot serial: H340372); Model Catalog: 690.375-US (Lot serial: H340372); Model Catalog: 690.380-US (Lot serial: FL00860); Model Catalog: 690.379-US (Lot serial: FL00860); Model Catalog: 690.380-US (Lot serial: H340372); Model Catalog: 690.375-US (Lot serial: FL00860)
  • Descripción del producto
    GRAPHIC CASES FOR 6.5MM & 7.3MM CANNULATED SCREW SETS
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC