Events

Retiro De Equipo (Recall) de Device Recall Fusio Liquid Dentin

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 Kerr Corporation.

¿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
    61239
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1115-2012
  • Fecha de inicio del evento
    2010-08-19
  • Fecha de publicación del evento
    2012-02-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107638
  • 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
    Material, tooth shade, resin - Product Code EBF
  • Causa
    A recall was initiated because pentron clinical has confirmed that the fusio liquid dentin is not as flowable as ideally expected.
  • Acción
    Pentron Clinical sent a Medical Device Recall letter dated September 8, 2010 (via USPS 1st class mail) to all affected customers. The letter identified the affected product, the reason for the recall and the actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete and fax back the enclosed recall return form. Customers were advised to contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.

Device

Device Recall Fusio Liquid Dentin
  • Modelo / Serial
    Lot Numbers: 3487864, 3491581
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) in the countries of Austria, Bulgaria, France, Great Britain, Netherlands, Japan, Lebanon, Malaysia and South Africa.
  • Descripción del producto
    Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC. || Product Usage: || The intended use of this device is as a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include self-etch base liner, restorations of carious lesions, Class I, III and V cavity preparations and pitt and fissure sealant.
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation
  • Dirección del fabricante
    Kerr Corporation, 1717 W Collins Ave, Orange CA 92867-5422
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA