Events

Retiro De Equipo (Recall) de SYNTHES (USA)MODULAR BLADE PLATE SYSTEM- 100MM SPIRAL BLADE

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
    103909
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-10-22
  • 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 is initiating a recall on all lots of the synthes spiral blade associated with the modular blade plate system due to a potential for an out of specification star grind teeth of the spiral plate. the potential of insufficient depth of the spiral blade star grind teeth could lead to loosening of the coupling screw. this may present a potential risk to the patient including loss of reduction construct failure and need for additional surgical intervention.

Device

SYNTHES (USA)MODULAR BLADE PLATE SYSTEM- 100MM SPIRAL BLADE
  • Modelo / Serial
    Model Catalog: 02.122.600 (Lot serial: ALL LOTS); Model Catalog: 02.122.601 (Lot serial: ALL LOTS); Model Catalog: 02.122.571 (Lot serial: ALL LOTS); Model Catalog: 02.122.586 (Lot serial: ALL LOTS); Model Catalog: 02.122.606 (Lot serial: ALL LOTS); Model Catalog: 02.122.605 (Lot serial: ALL LOTS); Model Catalog: 02.122.585 (Lot serial: ALL LOTS); Model Catalog: 02.122.570 (Lot serial: ALL LOTS); Model Catalog: 02.122.551 (Lot serial: ALL LOTS); Model Catalog: 02.122.615 (Lot serial: ALL LOTS); Model Catalog: 02.122.580 (Lot serial: ALL LOTS); Model Catalog: 02.122.581 (Lot serial: ALL LOTS); Model Catalog: 02.122.616 (Lot serial: ALL LOTS); Model Catalog: 02.122.575 (Lot serial: ALL LOTS); Model Catalog: 02.122.576 (Lot serial: ALL LOTS); Model Catalog: 02.122.620 (Lot serial: ALL LOTS); Model Catalog: 02.122.621 (Lot serial: ALL LOTS); Model Catalog: 02.122.565 (Lot serial: ALL LOTS); Model Catalog: 02.122.561 (Lot serial: ALL LOTS); Model Catalog: 02.122.560 (Lot serial: ALL LOTS); Model Catalog: 02.122.5
  • Descripción del producto
    SYNTHES MODULAR BLADE PLATE SYSTEM 100MM SPIRAL BLADE
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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