Events

Retiro De Equipo (Recall) de Device Recall Helioseal Clear

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 Ivoclar Vivadent, Inc..

¿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
    73308
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1026-2016
  • Fecha de inicio del evento
    2016-02-12
  • Fecha de publicación del evento
    2016-02-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143819
  • 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
    Sealant, pit and fissure, and conditioner - Product Code EBC
  • Causa
    Complaints were received claiming the material failed to polymerize under the curing light. after investigation, it was determined that a wrong photo-initiator was used in the production batch u30755 of helioseal clear. this failure can lead to incomplete curing of the sealant, if mono-wave led curing lights are used.
  • Acción
    Ivoclar Vivadent sent an Urgent Medical Device Recall letter dated February 11, 2016, to all consignees via Certified Mail, Return Receipt Requested. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to complete, sign and return the attached acknowledgement form and return it to Ivoclar Vivadent via fax (716) 691-2294 or e-mail at recall.us@ivoclarvivadent.com. Contact Ivoclar Vivadent Customer Service at 1-800-533-6825 as soon as possible between the hours of 8:00 am and 6:00 pm EST Monday through Friday and a representative will arrange to pick up your affected materials for return and credit. Please notify your customers of this issue and return the product to us. For questions, please contact Ivoclar Vivadent Customer Service at 800-533-6825.

Device

Device Recall Helioseal Clear
  • Modelo / Serial
    REF/Product Code/Art. No. 558521AN, Lot U29336 (exp. 10/5/2020); REF/Product Code/Art. No. 558520AN, Lots U33966, U35661, U50469 (exp. 10/5/2020)
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.
  • Descripción del producto
    Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
  • Manufacturer
    Ivoclar Vivadent, Inc.

Manufacturer

Ivoclar Vivadent, Inc.