Events

Retiro De Equipo (Recall) de Device Recall LPCCC2: Low Profile Abutment NonHexed Castable Cylinder

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Biomet 3i, LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    58921
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2884-2011
  • Fecha de inicio del evento
    2011-03-14
  • Fecha de publicación del evento
    2011-07-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100641
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Definitive Castable Cylinder for Dental Restoration - Product Code NHA
  • Causa
    Biomet 3i, palm beach gardens, fl is recalling the model lpccc2 low profile abutment, non-hexed castable cylinder, lots 2010101036 and 2010101037  exp. 10/2015. package labeling may not correctly describe the package contents. product was distributed in europe only.
  • Acción
    Biomet 3i sent a "Medical Device Advisory Notice" letter dated February 17, 2011 to all affected customers. The letter described the problem, instructed customers to returned any unused product and to confirm receipt of the notification. For additional information, please contact Customer Service at 800-342-5454.

Device

Device Recall LPCCC2: Low Profile Abutment NonHexed Castable Cylinder
  • Modelo / Serial
    Model LPCCC2 Lot# 2010101036 and 2010101037.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: http://webapps.cdrh.fda.gov/division-tracking/findTrackable.do?docNum=RCL110656&reviewType;=RCL
  • Descripción del producto
    LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i || 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
  • Dirección del fabricante
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “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