Events

Rappel de PFC SIGMA KNEE SYSTEM - TIBIAL INSERT TC3

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
    105937
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2005-06-02
  • 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
    An internal inspection found a small number of packages with an incomplete seal of the inner foil pouch which serves as an oxygen barrier during gamma irradiation and may affect long-term performance.

Device

PFC SIGMA KNEE SYSTEM - TIBIAL INSERT TC3
  • Modèle / numéro de série
    Model Catalog: (Lot serial: 86061A); Model Catalog: (Lot serial: 85407A); Model Catalog: (Lot serial: 86624A); Model Catalog: (Lot serial: 86335A); Model Catalog: (Lot serial: 86074A); Model Catalog: (Lot serial: 84118A); Model Catalog: (Lot serial: 86065A); Model Catalog: (Lot serial: 84498A); Model Catalog: (Lot serial: 86612A); Model Catalog: (Lot serial: 85873A); Model Catalog: (Lot serial: 86538); Model Catalog: (Lot serial: 86589A); Model Catalog: (Lot serial: 86263A); Model Catalog: (Lot serial: 86187A); Model Catalog: (Lot serial: 84124A); Model Catalog: (Lot serial: Y5YA94000); Model Catalog: (Lot serial: 84328A); Model Catalog: (Lot serial: Y42F64000); Model Catalog: (Lot serial: YP5DA4000); Model Catalog: (Lot serial: YP2JA4000); Model Catalog: (Lot serial: YH8BL4000); Model Catalog: (Lot serial: YH8BJ4000); Model Catalog: (Lot serial: Y4SDK4000); Model Catalog: (Lot serial: X6AA64000); Model Catalog: (Lot serial: YP7CW4000); Model Catalog: (Lot serial: YE5CC4000); Model
  • Description du dispositif
    PFC SIGMA KNEE SYSTEM - TIB INSERT TC3
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.