Retiro De Equipo (Recall) de Elements Gutta Percha and Elements RealSeal Cartridges

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 Sybronendo.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Gutta Percha - Product Code EKM
  • Causa
    The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the elements obturation unit with which the cartridges are used. more specifically, there exists a possibility that if the lock nut were to fail, the cart.
  • Acción
    The recall communications was initiated on November 06, 2009 with the firm forwarding a Recall Letter to the affected consignees via US Postal Service 1st class mail. The recall letter informed the consignees of the reason for recall, the hazard and the affected products. Consignees were instructed to call SybronEndo Customer Care at 1-800-346-3636 directly to handle returns & replacements. In addition, consignees were asked to complete the enclosed Recall Return Form and return it by fax to 909-962-5605. The recall notice also instructed consignees that are an authorized SybronEndo distributor to identify and recover the affected product lots listed above that may have been shipped to their customers.


  • Modelo / Serial
    Lot Numbers: 06 0959663, 06 0957595, 07 0987641, 08 0992277, 05 0941553, 05 0948690, 06 0955241, 07 0977947, 07 0987642, 08 0992278, 08 0998612
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide and Worldwide to: USA, Canada, Chile, China, Ecuador, Guatemala, Hong Kong, Japan, Malaysia, Singapore, Taiwan and Venezuela
  • Descripción del producto
    Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002
  • Manufacturer


  • Dirección del fabricante
    Sybronendo, 1717 W Collins Ave, Orange CA 92867
  • Source