Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ZIMMER BIOMET CANADA 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
  • ID de l'événement
  • Classe de risque de l'événement
  • Date de mise en oeuvre de l'événement
  • Pays de l'événement
  • Source de l'événement
  • 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
    Potential for intermittent cracks in the raw material batch used to produce the affected products.The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.


  • Modèle / numéro de série
    Model Catalog: 42-5399-083-02 (Lot serial: 63688256); Model Catalog: 42-5321-083-01 (Lot serial: 63535352); Model Catalog: 42-5399-083-02 (Lot serial: 63576041); Model Catalog: 42-5399-083-01 (Lot serial: 63576041); Model Catalog: 42-5399-083-02 (Lot serial: 63531871); Model Catalog: 42-5399-083-01 (Lot serial: 63531871); Model Catalog: 42-5399-083-02 (Lot serial: 63576035 63649575 63693589); Model Catalog: 42-5399-083-01 (Lot serial: 63576035 63649575 63693589); Model Catalog: 42-5399-083-02 (Lot serial: 63531869); Model Catalog: 42-5399-083-01 (Lot serial: 63531869); Model Catalog: 42-5321-083-02 (Lot serial: 63683139); Model Catalog: 42-5321-083-01 (Lot serial: 63683139); Model Catalog: 42-5321-083-02 (Lot serial: 63613121); Model Catalog: 42-5321-083-01 (Lot serial: 63613121); Model Catalog: 42-5321-083-02 (Lot serial: 63607357); Model Catalog: 42-5321-083-01 (Lot serial: 63607357); Model Catalog: 42-5321-083-02 (Lot serial: 63535352); Model Catalog: 42-5399-083-01 (Lot serial: 63688256)
  • Description du dispositif
    Persona the Personalized Knee System Tibila Sizing Plate;PERSONA THE PERSONALIZED KNEE SYSTEM NATURAL Tibia cemmented 5 degree stemmed provisional
  • Manufacturer


  • Adresse du fabricant
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source