Events

Avis De Sécurité sur Zimmer® segmental system of polyethylene cartridge-size B & size C

Selon Agency for Medical Products and Medical Devices of Croatia, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Croatia qui a été fabriqué par Zimmer, Inc..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    2014_zimmer_segmental_system_polyethylene_insert_size_b_and_size_c_1006
  • Date
    2014-01-17
  • Pays de l'événement
    Croatia
  • Source de l'événement
    AMPMDC
  • URL de la source de l'événement
    http://www.halmed.hr/en/Medicinski-proizvodi/Sigurnosne-informacije/Sigurnosne-obavijesti-o-medicinskim-proizvodima/2014/Zimmer-segmental-system-polyethylene-insert-size-B-and-size-C/1006
  • Notes / Alertes
    Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, 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 Croatia.
  • Notes supplémentaires dans les données
    The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Zimmer, Inc., SAD on the changes in instructions for use and applicable surgical technique due to complaint reports to hyperextension of polyethylene inserts.
    Here you may view the safety information addressed to users.

Device

Zimmer® segmental system of polyethylene cartridge-size B & size C

Manufacturer

Zimmer, Inc.
  • 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
    AMPMDC