Events

Retiro De Equipo (Recall) de Device Recall Bond1 Primer/Adhesive

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
    61265
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1142-2012
  • Fecha de inicio del evento
    2010-05-27
  • Fecha de publicación del evento
    2012-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107686
  • 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
    Agent, tooth bonding, resin - Product Code KLE
  • Causa
    The recall was initiated because pentron clinical has confirmed that various lots of bond-1 primer/adhesive have been found to have gelled and therefore becomes unusable.
  • Acción
    Pentron Clinical sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 7, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to complete and return an enclosed Recall Return Form via fax at 1-877-677-8844. 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 Bond1 Primer/Adhesive
  • Modelo / Serial
    Item # Bottle Lot # Package Lot# N01I 185597, 192338, 202233 186658, 194491, 202885 N01IAA 185597, 192372 184876, 185342, 192372 N01IAB 183352, 183845, 202233 183466, 183948, 203221 N04 191010 200816 N04B 185597 183127 N31B 184256, 197303 184464, 204774 N33 184256 180766
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Germany, Canada, Ecuador, Egypt, Hong Kong, India, Israel, Japan, Kenya, Lebanon, Morocco, Saudi Arabia, Singapore, El Salvador, Thailand, Turkey, Taiwan, UAE, Vietnam, Armenia, Austria, Belgium, Bulgaria, Byelorussia, Cyprus, Germany, Spain, Russia, Finland, England, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Poland, Romania, Sweden, and Serbia.
  • Descripción del producto
    Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding || agent. || Item # Item Description || N01I Bond-1 Prim/Adhesive Kit || N01IAA Bond-1 Primer/Adhesive 4ml || N01IAB Bond-1 Primer/Adhesive 6ml || N04 Lute-it w/ Bond-1 kit || N04B Lute-t w/Bond-1 Intro Kit || N31B Bond-1 C&B; Prim/Adhesive || N33 Cement-it Universal C&B; Resin. || The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
  • 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