Events

Retiro De Equipo (Recall) de ATTUNE CONV FB PS ARTICULATION SURFACE

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
    113931
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-06-18
  • 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 is issuing a device correction for all lots of attune tibial articulation surface instruments used in trialing with the attune knee system. the device correction is being issued due to the potential for the balseal which is a small wire spring coil located on the post feature of the articulation surface instruments to become damaged and disassociate (come off). the balseal is constructed from implant grade stainless steel. if the balseal is separated from the post it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

Device

ATTUNE CONV FB PS ARTICULATION SURFACE
  • Modelo / Serial
    Model Catalog: 2545-01968 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-01967 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-01966 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-01964 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-01965 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-01963 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-962 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-961 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-01-000 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-999 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-992 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-991 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-980 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-979 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-972 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-9
  • Descripción del producto
    ATTUNE CONV FB PS ARTICULATION SURFACE
  • 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