Events

Rappel de PERSONA THE PERSONALIZED KNEE SYSTEM - ARTICULAR SURFACE INSERTER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ZIMMER 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
    64817
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-10-16
  • 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
    Zimmer is initiating a lot specific recall of persona tibial articular surface inserters due to the potential for deformation of the tip. the instrument may not remain attached to the tibial baseplate during insertion of the articular surface. an investigation found that a group of 360 units did not undergo a heat treatment hardening step resulting in a lack in material strength that may contribute to deformation of the tip over time.

Device

PERSONA THE PERSONALIZED KNEE SYSTEM - ARTICULAR SURFACE INSERTER
  • Modèle / numéro de série
    Model Catalog: 42-5299-001-00 (Lot serial: 56574317); Model Catalog: 42-5299-001-00 (Lot serial: 56574291)
  • Description du dispositif
    PERSONA ARTICULAR SURFACE INSERTER
  • Manufacturer
    ZIMMER INC.

Manufacturer

ZIMMER INC.
  • Adresse du fabricant
    WARSAW
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • 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
    HC