Events

Alerte De Sécurité sur Dental implants and prosthetic components

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Unico Distribuidor: Biomet 3i Inc. || Biomet 3i Dental Iberica (Vlc) C/Islas Baleares || Biomet Spain Orthopadic S.L (España), Para Biomet || Biomet 3i Dental Iberica, Sl || Lx Precision (Shanghai) Co., Ltd. De China Para Biomet 3i De || Estados Unidos De América. || Changzhou Biomet Medical Devices Co., Ltd (China) Para || Biomet 31 Estados Unidos.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    R1609-399
  • Numéro de l'événement
    2009DM-0004307
  • Date
    2016-09-23
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=121
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer reports that it has detected that the medical device was packaged but was not sealed, which would compromise its sterile barrier, leading to potentially serious adverse events occurring in patients.

Device

Dental implants and prosthetic components

Manufacturer

Unico Distribuidor: Biomet 3i Inc. || Biomet 3i Dental Iberica (Vlc) C/Islas Baleares || Biomet S...
  • 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
    NIDFSINVIMA