Events

Retiro De Equipo (Recall) de Device Recall Artiste Flowable and Flow Tec (private label of Artiste Flowable)

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 Sybron Dental Specialties.

¿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
    60693
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0990-2012
  • Fecha de inicio del evento
    2011-03-03
  • Fecha de publicación del evento
    2012-02-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107262
  • 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
    The recall was initiated because pentron clinical has confirmed that the flow tec nano-hybrid flowable composite material has been found to be difficult to extrude.
  • Acción
    Pentron Clinical sent an initial "URGENT: MEDICAL DEVICE RECALL" letter dated April 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and fax back an enclosed recall return form in order to confirm their receipt of the recall notification. A second "URGENT: MEDICAL DEVICE RECALL" letter dated November 10, 2011 was sent to all affected customers because Pentron Clinical expanded the recall. On December 8, 2011 another recall communication was forwarded to all affected customers to change the wording on the letter to make it more clear to the customers about the recall expansion. Contact Pentron Clinical Customer Service at 1-800-551-0283 for questions regarding this recall.

Device

Device Recall Artiste Flowable and Flow Tec (private label of Artiste Flowable)
  • Modelo / Serial
    All Lots
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA (nationwide) and the countries of Canada, Egypt, France, Germany, Italy, and Spain.
  • Descripción del producto
    Flow Tec Nano-Hybrid Flowable Affected Product || Syringe Part No. Value Pack Part. No. Shade || BEN3784-514 BEN3786-754 A1 || BEN3784-532 BEN3786-763 A2 || BEN3784-541 BEN3784-738 A3 || BEN3784-550 BEN3784-747 A3.5 || BEN3784-569 BEN3784-756 A4 || BEN3784-578 BEN3784-765 B1 || BEN3784-596 BEN3784-774 B2 || BEN3784-603 BEN3784-783 C1 || BEN3784-612 BEN3784-792 C2 || BEN3784-621 BEN3784-809 C3 || BEN3784-649 BEN3784-818 D2 || BEN3784-722 BEN3784-818 Universal Opaque || BEN3784-685 BEN3784-827 A0 || BEN3784-701 BEN3784-836 Incisal. || The intended use of this device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

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