Events

Alerte De Sécurité sur Implant System and Dental 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 Zimmer Dental Inc. || Zest Anchors, Llc Also Dba Zest Dental Solutions And Danville Materials.

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
    R1710-515
  • Numéro de l'événement
    2015DM-0003183-R1
  • Date
    2017-10-30
  • 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=65
  • 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 has detected that the device may contain a manufacturing condition that affects the geometry of the driver's hexagonal characteristic, which prevents the components from being properly assembled, leading to possible delays in procedures and adverse events on the patients.

Device

Implant System and Dental Components
  • Modèle / numéro de série
    GEMLOCK 2.5mm RHD2.5, TSVKIT, specific lots
  • Description du dispositif
    Dental ZIMMER implant systems are designed for use in the maxilla or mandible for immediate loading or loading after the conventional healing period has elapsed. These implants can be used to replace the absence of one or more teeth. Immediate loading is indicated when there is good primary stability and adequate occlusal loading
  • Manufacturer
    Zimmer Dental Inc. || Zest Anchors, Llc Also Dba Zest Dental Solutions And Danville Materials

Manufacturer

Zimmer Dental Inc. || Zest Anchors, Llc Also Dba Zest Dental Solutions And Danville Materials
  • 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