Events

Retiro De Equipo (Recall) de DELTA XTEND REVERSE SHOULDER SYSTEM - MODULAR ECCENTRIC EPIPHYSIS

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
    72979
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-09-15
  • 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 synthes is initiating a voluntary recall. for the recalled lots an investigation determined that lots produced in a specific machine were manufactured in a manner in which the post's diameter is out-of-specification. further investigation determined that the issue is related to the circularity of the cylinder. the circularity issue may cause the epiphysis to interfere with the stem and the two implants (epiphysis and stem) may not be able to be assembled.

Device

DELTA XTEND REVERSE SHOULDER SYSTEM - MODULAR ECCENTRIC EPIPHYSIS
  • Modelo / Serial
    Model Catalog: 130720203 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720201 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720101 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720102 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720202 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720103 (Lot serial: >100 NUMBERS CONTACT MFG)
  • Descripción del producto
    DELTA XTEND REVERSE SHOULDER SYSTEM - MODULAR ECCENTRIC EPIPHYSIS;DELTA XTEND REVERSE SHOULDER SYSTEM -MODULAR CEMENTED EPIPHYSIS
  • 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