Events

Rappel de Device Recall UCLA Abutment Hexed Castable Cylinder 3.4mm

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Biomet 3i, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72000
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2760-2015
  • Date de mise en oeuvre de l'événement
    2015-07-29
  • Date de publication de l'événement
    2015-09-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139565
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Abutment, implant, dental, endosseous - Product Code NHA
  • Cause
    Mucc2, non-hexed, castable abutment cylinders, has been labeled and distributed as a mucc1c, hexed, castable abutment cylinders for this one lot only.
  • Action
    Biomet sent a Medical Device Recall Notice dated July 27, 2015, to all their clinicians informing them about the recall and to complete the attached recall return response form and any unused product to be replaced at no charge. Contact information 1-800-342-5454

Device

Device Recall UCLA Abutment Hexed Castable Cylinder 3.4mm
  • Modèle / numéro de série
    Model # MUCC1C LOT # 1186054
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution including Italy and Uruguay.
  • Description du dispositif
    UCLA Abutment Hexed Castable Cylinder 3.4mm || Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
  • Manufacturer
    Biomet 3i, LLC

Manufacturer

Biomet 3i, LLC
  • Adresse du fabricant
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • 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
    USFDA