Events

Retiro De Equipo (Recall) de GENESIS II FINNED STEM TIBIAL PUNCH

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
    16626
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2006-09-01
  • 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
    Punches were not manufactured to our specifications and the tip of the punch is welded on and not one piece as specified. this can cause the tip of the punch to break off during use.

Device

GENESIS II FINNED STEM TIBIAL PUNCH
  • Modelo / Serial
    Model Catalog: P/N 71434306 (Lot serial: EX. 00511384).); Model Catalog: P/N 71434304 (Lot serial: EX. 00511384).); Model Catalog: P/N 71434301 (Lot serial: ALL LOTS PRIOR TO); Model Catalog: P/N 71434302 (Lot serial: ALL LOTS PRIOR TO); Model Catalog: P/N 71434304 (Lot serial: ALL LOTS PRIOR TO); Model Catalog: P/N 71434306 (Lot serial: ALL LOTS PRIOR TO); Model Catalog: P/N 71434301 (Lot serial: 06MM***** SEQUENCE INCLUDING); Model Catalog: P/N 71434302 (Lot serial: 06MM***** SEQUENCE INCLUDING); Model Catalog: P/N 71434304 (Lot serial: 06MM***** SEQUENCE INCLUDING); Model Catalog: P/N 71434306 (Lot serial: 06MM***** SEQUENCE INCLUDING); Model Catalog: P/N 71434301 (Lot serial: THOSE ITEMS WITH SUFFIXES); Model Catalog: P/N 71434302 (Lot serial: THOSE ITEMS WITH SUFFIXES); Model Catalog: P/N 71434304 (Lot serial: THOSE ITEMS WITH SUFFIXES); Model Catalog: P/N 71434306 (Lot serial: THOSE ITEMS WITH SUFFIXES); Model Catalog: P/N 71434301 (Lot serial: (EX. 05LM03346B AND WITHOUT); Model Catalog: P/N 71434302
  • Descripción del producto
    GENESIS II nonporous tibial punch
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

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