Events

Retiro De Equipo (Recall) de PFC SIGMA KNEE SYSTEM - TIBIAL INSERT TC3

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
    105937
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2005-06-02
  • 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
    An internal inspection found a small number of packages with an incomplete seal of the inner foil pouch which serves as an oxygen barrier during gamma irradiation and may affect long-term performance.

Device

PFC SIGMA KNEE SYSTEM - TIBIAL INSERT TC3
  • Modelo / Serial
    Model Catalog: (Lot serial: 86061A); Model Catalog: (Lot serial: 85407A); Model Catalog: (Lot serial: 86624A); Model Catalog: (Lot serial: 86335A); Model Catalog: (Lot serial: 86074A); Model Catalog: (Lot serial: 84118A); Model Catalog: (Lot serial: 86065A); Model Catalog: (Lot serial: 84498A); Model Catalog: (Lot serial: 86612A); Model Catalog: (Lot serial: 85873A); Model Catalog: (Lot serial: 86538); Model Catalog: (Lot serial: 86589A); Model Catalog: (Lot serial: 86263A); Model Catalog: (Lot serial: 86187A); Model Catalog: (Lot serial: 84124A); Model Catalog: (Lot serial: Y5YA94000); Model Catalog: (Lot serial: 84328A); Model Catalog: (Lot serial: Y42F64000); Model Catalog: (Lot serial: YP5DA4000); Model Catalog: (Lot serial: YP2JA4000); Model Catalog: (Lot serial: YH8BL4000); Model Catalog: (Lot serial: YH8BJ4000); Model Catalog: (Lot serial: Y4SDK4000); Model Catalog: (Lot serial: X6AA64000); Model Catalog: (Lot serial: YP7CW4000); Model Catalog: (Lot serial: YE5CC4000); Model
  • Descripción del producto
    PFC SIGMA KNEE SYSTEM - TIB INSERT TC3
  • 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