Events

Avis De Sécurité sur rox * endobon xenograft bone granulator for implant.

Selon Ministero della Salute (Health Ministry), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Italy qui a été fabriqué par ZIMMER BIOMET FRANCE.

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
    6378
  • Date
    2016-02-17
  • Pays de l'événement
    Italy
  • Source de l'événement
    MSHM
  • URL de la source de l'événement
    http://www.salute.gov.it/portale/news/p3_2_1_3_1_1.jsp?lingua=italiano&menu=notizie&p=avvisi&tipo=dispo&id=6378
  • Notes / Alertes
    Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 data from the U.S. and Italy.
  • Notes supplémentaires dans les données
  • Action
    Urgent recall of a medical device. guardian codes and affected lots specified in the notice.

Device

rox * endobon xenograft bone granulator for implant.

Manufacturer

ZIMMER BIOMET FRANCE
  • 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
    MSHM