Rappel de PFC SIGMA KNEE SYSTEM - STABILIZED TIBIAL INSERT

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
    87806
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2007-10-11
  • Pays de l'événement
  • 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
    An unapproved sealing technique is believed to have possibly been used on these devices. a similar technique was previously determined to have caused a loss of vacuum on the inner foil pouch.

Device

  • Modèle / numéro de série
    Model Catalog: 960452 (Lot serial: 81354A); Model Catalog: 960441 (Lot serial: 81354A); Model Catalog: 960440 (Lot serial: 81354A); Model Catalog: 960471 (Lot serial: 81226A); Model Catalog: 960453 (Lot serial: 81226A); Model Catalog: 960452 (Lot serial: 81226A); Model Catalog: 960441 (Lot serial: 81226A); Model Catalog: 960440 (Lot serial: 81226A); Model Catalog: 960471 (Lot serial: 80341A); Model Catalog: 960453 (Lot serial: 80341A); Model Catalog: 960452 (Lot serial: 80341A); Model Catalog: 960441 (Lot serial: 80341A); Model Catalog: 960440 (Lot serial: 80341A); Model Catalog: 960471 (Lot serial: 80340A); Model Catalog: 960453 (Lot serial: 80340A); Model Catalog: 960452 (Lot serial: 80340A); Model Catalog: 960441 (Lot serial: 80340A); Model Catalog: 960440 (Lot serial: 80340A); Model Catalog: 960471 (Lot serial: 80347A); Model Catalog: 960453 (Lot serial: 80347A); Model Catalog: 960452 (Lot serial: 80347A); Model Catalog: 960441 (Lot serial: 80347A); Model Catalog: 960440 (Lot serial: 80347A); Model Catal
  • Description du dispositif
    PFC SIGMA KNEE SYSTEM - STABILIZED TIBI
  • Manufacturer

Manufacturer