Events

Retiro De Equipo (Recall) de TANDEM INTL BIPOLAR SHELL/LINER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SMITH & NEPHEW 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
    69209
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-09-08
  • 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
    The affected devices were manufactured with an out of specification retainer groove location. in the event the failure occurs it would be obvious to the user in that the devices would not provide an audible indicator that the poly lock has engaged. in the event the construct is tight the user should notice the limited range of motion. however in the worst case situation if the device gives a false indicator of locking the user would not recognize the failure.

Device

TANDEM INTL BIPOLAR SHELL/LINER
  • Modelo / Serial
    Model Catalog: 71324040 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324041 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324057 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324055 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324053 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324054 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324052 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324051 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324050 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324049 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324048 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324047 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324046 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324045 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324044 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324043 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog:
  • Descripción del producto
    TANDEM INTL BIPOLAR SHELL/LINER
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Smith & Nephew plc
  • Source
    HC