Events

Retiro De Equipo (Recall) de RECLAIM POLY TAPER PROTECTOR

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
    130988
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-07-02
  • 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
    This voluntary device correction is being initiated because the product the reclaim taper sleeve protector instrument (sold separately or assembled to the reclaim stem) can be difficult to remove from the distal stem both before surgery and after proximal reaming. the immediate remedy is for all users to discard the affected taper sleeve protector prior to stem implantation.

Device

RECLAIM POLY TAPER PROTECTOR
  • Modelo / Serial
    Model Catalog: 297500110 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 1977-25-290 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-26-190 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-25-190 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-24-240 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-24-190 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-23-290 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-23-240 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-23-190 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-22-240 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-22-190 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-21-290 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-21-240 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-21-190 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-20-290 (Lot serial: >1000 NUMBERS CONTACT MFR); Model C
  • Descripción del producto
    RECLAIM TAPER SLEEVE PROTECTOR
  • 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