Events

Rappel de Device Recall Low Profile Abutment

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
    62578
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2271-2012
  • Date de mise en oeuvre de l'événement
    2012-05-31
  • Date de publication de l'événement
    2012-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111086
  • 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
    Biomet 3i conducted a recall on the device low profile abutment, non-hexed castable cylinder due to some packages labeled lpccc1, hexed castable cylinder possibly containing lpccc2, non-hexed castable cylinders.
  • Action
    Biomet 3i sent a "MEDICAL DEVICE ADVISORY NOTICE" dated May 31, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-342-5454 for questions regarding this recall.

Device

Device Recall Low Profile Abutment
  • Modèle / numéro de série
    Lots: 2010100001, 2010080684, and 2010090191
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.
  • Description du dispositif
    Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** || Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.
  • 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