Events

Retiro De Equipo (Recall) de Bisco BISCEM SelfAdhesive Luting Cement Translucent

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 Bisco 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
    47871
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1696-2008
  • Fecha de inicio del evento
    2008-04-28
  • Fecha de publicación del evento
    2008-08-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70387
  • 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
    Dental Cement - Product Code EMA
  • Causa
    During product stability testing, bisco determined that after 15 months of storage, biscem¿ self-adhesive luting cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. bisco also determined that product component(s) may thicken slightly over time.
  • Acción
    Bisco sent Urgent Medical Device recall letters dated 4/25/08 to the U.S. consignees via 1st class mail on 4/28/08. The letters informed the users that after 15 months of storage, BISCEM¿ Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Future production lots will be labeled with a shelf life of 1 year with a requirement to refrigerate the product when not in use. The accounts were requested to destroy their remaining stocks of the product and record the number of used or partially used syringes destroyed, indicating the lot numbers of the units destroyed on the enclosed response form and fax it back to Bisco at 847-534-66101. Questions were directed to Bisco Dental Products Customer Service at 1-800-247-3368.

Device

Bisco BISCEM SelfAdhesive Luting Cement Translucent
  • Modelo / Serial
    all lots of Item numbers D-45011P, D-45001S and G-91700K
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide including Puerto Rico and internationally to Argentina, Australia, Bulgaria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Jordan, Korea, Lebanon, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Portugal, Romania, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Vietnam
  • Descripción del producto
    Dental Cement-Bisco BISCEM¿ Dual-Cured Self-Adhesive Resin Cement, Translucent; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the pulp.
  • Manufacturer
    Bisco Inc

Manufacturer

Bisco Inc
  • Dirección del fabricante
    Bisco Inc, 1100 W Irving Park Rd, Schaumburg IL 60193-3569
  • Empresa matriz del fabricante (2017)
    Bisco Inc.
  • Source
    USFDA