Events

Retiro De Equipo (Recall) de Device Recall 37 Etching Gel1ml syringe

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/pentron Dba Kerr Corporation And Pentron Clinical.

¿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
    60114
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0153-2012
  • Fecha de inicio del evento
    2011-03-31
  • Fecha de publicación del evento
    2011-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104457
  • 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
    Pentron clinical is voluntarily recalling all lots of products labeled as 37% phosphoric acid etching gel produced since april 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label.
  • Acción
    The firm, Pentron Clinical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated May 31, 2011, with attached Return Form (via USPS 1st class mail) to all their consignees/customers. The letter describes the product, problem and action to be taken. All consignees/customers were instructed to complete the Recall Return Form via fax to: 1-877-677-8844 and to return any affected product in their inventory. Affected products will have expiration dates between April 2011 and April 2015. Consignees/customers with questions can contact Pentron Clinical Customer Service at (800) 551-0283 directly to handle the arrangements of a quick return and replacement.

Device

Device Recall 37 Etching Gel1ml syringe
  • Modelo / Serial
    all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Armenia, Austria, Australia, Antigua & Barbuda, Barbados, Belarus, Bulgaria, Canada, Czech Republic, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Poland, Romania, Russia, St. Vincent & Grenadine, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, Ukraine, UK, and Vietnam.
  • Descripción del producto
    37% Etching Gel-1ml syringe 50 pk, part # T06B || The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.
  • Manufacturer
    Kerr/pentron Dba Kerr Corporation And Pentron Clinical

Manufacturer

Kerr/pentron Dba Kerr Corporation And Pentron Clinical
  • Dirección del fabricante
    Kerr/pentron Dba Kerr Corporation And Pentron Clinical, 1717 W. Collins Ave, Orange CA 92867
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA