Events

Rappel de ATTUNE CONV FB PS ARTICULATION SURFACE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    113931
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-06-18
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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
  • Description du dispositif
    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.