Events

Retiro De Equipo (Recall) de Device Recall T3 Dental Implant

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
    65005
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1960-2013
  • Fecha de inicio del evento
    2013-05-10
  • Fecha de publicación del evento
    2013-08-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117652
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Causa
    A small number of outer implant boxes may be mislabeled. the inner tray, containing the implant, is label correctly. this condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
  • Acción
    The firm issued "Urgent Medical Device Recall" notification letters to their customers dated May 10, 2013. The notification described the issue and provided recommendations actions regarding affected product. Customers with questions may contact 1 800-342-5454.

Device

Device Recall T3 Dental Implant
  • Modelo / Serial
    Lot number: 2012111613 Exp 2017/12 Catalog #: BOPS6510
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.
  • Descripción del producto
    Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
  • 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