Events

Retiro De Equipo (Recall) de Device Recall Osseotite Certain Implant(s) & Osseotite Tapered Certain Implant(s)

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
    58326
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2139-2011
  • Fecha de inicio del evento
    2011-03-10
  • Fecha de publicación del evento
    2011-05-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98994
  • 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 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 data.
  • Notas adicionales en la data
    Dental implant surgical tray - Product Code O-FY
  • Causa
    Biomet 3i is recalling their product osseotite certain implant device ioss413. the internal thread was not manufactured correctly.
  • Acción
    BIOMET 3i sent an Urgent Medical Device Recall Letter on March 14, 2011, to all affected customers via emial or fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told to contact Customer Service at 1-800-342-5454. Customers were instructed to respond with the attached Response Fax or email DomesticComplaints@Biomet.com. If customers still had implant(s) in their inventory, they were to return the implant(s) to BIOMET 3i using the following address: BIOMET 3i Regulatory Compliance Department 4555 Riverside Drive Palm Beach Gardens, Florida 33410 Incident No. CD117886 A replacement implant(s) will be sent to them one the product is returned. For questions regarding this recall call 561-776-6906 (EST 8:00am to 5:00pm).

Device

Device Recall Osseotite Certain Implant(s) & Osseotite Tapered Certain Implant(s)
  • Modelo / Serial
    Lot number: 2009110838.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AK, FL, GA, NC, NJ, NY, SC and the countries of Canada, Europe, Japan, and South America.
  • Descripción del producto
    ***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain*** || Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
  • 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