Events

Avis De Sécurité sur dermacarriers ™ and dermacarriers ii skin grafts

Selon Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Poland qui a été fabriqué par COMESA POLSKA.

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
    2690
  • Date
    2008-05-13
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/komunikat-firmy-comesa-polska-o-wycofaniu-z-obrotu-i-u%C5%BCywania-torebek-na-przeszczepy-sk%C3%B3rne
  • Notes / Alertes
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notes supplémentaires dans les données
  • Action
    Statement of COMESA POLSKA on the withdrawal from the market and use of Dermacarriers ™ and Dermacarriers II Dermacarriers II skin grafts from Zimmer Orthopedic Surgical Products (13/05/2008)

Device

dermacarriers ™ and dermacarriers ii skin grafts

Manufacturer

COMESA POLSKA
  • 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
    ORMPMDBP