Events

Retiro De Equipo (Recall) de ASR 300 SIZE 44 ACETABULAR CUPS

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
    51219
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-08-26
  • 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
    Depuy issued a field safety notice in march 2010 (recall number 53553) after receiving data that demonstrated the asr system had a higher than expected revision rate at three years when used with smaller head sizes. new data now shows a higher than expected revision rate at five years across the entire size range. the manufacturer is therefore issuing a voluntary recall of all asr products.

Device

ASR 300 SIZE 44 ACETABULAR CUPS
  • Modelo / Serial
    Model Catalog: 999830754 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830752 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830750 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830748 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830746 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830744 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 9998-04-348 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-04-146 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-03-944 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-06-370 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-06-168 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-966 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-764 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-562 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-360 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-158 (Lo
  • Descripción del producto
    ASR 300 SPIKED ACETABULAR SHELLS
  • 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