Events

Rappel de Biolox Delta Head, Durasul

Selon Valvira - National Supervisory Authority for Welfare and Health (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Finland qui a été fabriqué par Zimmer GmbH.

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
    2015-0047
  • Date
    2015-01-16
  • Pays de l'événement
    Finland
  • Source de l'événement
    VNSAWH
  • Notes / Alertes
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notes supplémentaires dans les données
    Source: FSCA
  • Cause
    Device failure / feature before use - packing - sterility.

Device

Biolox Delta Head, Durasul

Manufacturer

Zimmer GmbH
  • 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
    VNSAWH