Events

Retiro De Equipo (Recall) de SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB SYSTEM-INFERIOR CRADLE

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
    43409
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-08-05
  • 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
    This recall is being initiated because the last hole on the veptr caudal rib supports subject to this recall may be partially formed. fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to extension bar breakage which could require unplanned surgical intervention to exchange components. in addition to the risks inherent to re-operation potential effects on the patient could also include pain loss of deformity correction and/or soft tissue/visceral injury.

Device

SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB SYSTEM-INFERIOR CRADLE
  • Modelo / Serial
    Model Catalog: 497.231 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.230 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.229 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.228 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.227 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.226 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.225 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.249 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.248 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.247 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.100 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.099 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.098 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.246 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.245 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.244 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog:
  • Descripción del producto
    (VEPTR) VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB CAUDAL RIB SUPPORTS
  • 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