Events

Retiro De Equipo (Recall) de T-PAL SPACER

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
    51652
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-09-13
  • 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 medical device labelling recall related to the synthes t-pal spacer system specifically regarding the use of the t-pal spacer with allograft material. this action has been initiated following a regulatory review of all labelling and promotional materials associated with the t-pal spacer system which is currently only indicated for use with autograft. there have been no additional risks to the patient identified associated with the use of the t-pal spacer system with allograft material.

Device

T-PAL SPACER
  • Modelo / Serial
    Model Catalog: 08.812.217 (Lot serial: ALL LOTS); Model Catalog: 08.812.007 (Lot serial: ALL LOTS); Model Catalog: 08.812.215 (Lot serial: ALL LOTS); Model Catalog: 08.812.214 (Lot serial: ALL LOTS); Model Catalog: 08.812.213 (Lot serial: ALL LOTS); Model Catalog: 08.812.212 (Lot serial: ALL LOTS); Model Catalog: 08.812.211 (Lot serial: ALL LOTS); Model Catalog: 08.812.210 (Lot serial: ALL LOTS); Model Catalog: 08.812.209 (Lot serial: ALL LOTS); Model Catalog: 08.812.208 (Lot serial: ALL LOTS); Model Catalog: 08.812.207 (Lot serial: ALL LOTS); Model Catalog: 08.812.017 (Lot serial: ALL LOTS); Model Catalog: 08.812.016 (Lot serial: ALL LOTS); Model Catalog: 08.812.015 (Lot serial: ALL LOTS); Model Catalog: 08.812.014 (Lot serial: ALL LOTS); Model Catalog: 08.812.013 (Lot serial: ALL LOTS); Model Catalog: 08.812.012 (Lot serial: ALL LOTS); Model Catalog: 08.812.011 (Lot serial: ALL LOTS); Model Catalog: 08.812.010 (Lot serial: ALL LOTS); Model Catalog: 08.812.009 (Lot serial: ALL LOTS); Model Catalog: 08.812.0
  • Descripción del producto
    T-PAL SPACER BROCHURE
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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