Events

Retiro De Equipo (Recall) de Device Recall Osseotite NT Certain

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
    58328
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2245-2011
  • Fecha de inicio del evento
    2011-03-10
  • Fecha de publicación del evento
    2011-05-24
  • 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=98995
  • 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
    Implant, endosseous, root form - Product Code O-FY
  • Causa
    Biomet 3i is recalling their product osseotite nt certain dental implant int411 . the internal thread was not manufactured correctly.
  • Acción
    Biomet 3i, LLC sent an Urgent Medical Device Recall letter dated March 14, 2011, via email or fax to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A small percentage of the implant lots may have a condition affecting the internal thread. The condition, if present, will prevent the cover screw, temporary healing abutment, final restorative abutment, etc. from engaging the implant. Customers were instructed to contact Customer Service at 1-800-342-5454 if this condition is recognized upon attempting to assemble any of the screws with the implant. Customers were instructed to return the implant to the firm for replacement to the following address: BIOMET 3i Regulatory Compliance Department 4555 Riverside Drive Palm Beach Gardens, Florida 33410 Incident No. CC117886 Customers were also instructed to respond with the attached Response Fax or email to DomesticComplaints@Biomet.com. For any questions regarding this recall call 561-776-6906.

Device

Device Recall Osseotite NT Certain
  • Modelo / Serial
    Lot #963841
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Europe, Japan, Asia, and South America.
  • Descripción del producto
    ***REF INT411***OSSEOTITE Tapered Certain Implant 4 x 11.5mm***Sterile Using Radiation***Rx Only***BIOMET 3i Dental lberica S.L.WTC Almeda Park, Ed, 1 Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain***Phone +34 934-705-500; Fax +34 933-717-849. || 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