Events

Retiro De Equipo (Recall) de Kerr Revolution Formula 2 Flowable Light Cure Composite

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 Patterson Dental Supply, 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
    57242
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0716-2011
  • Fecha de inicio del evento
    2010-10-15
  • Fecha de publicación del evento
    2010-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95649
  • 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
    Tooth Shade Resin Material - Product Code EBF
  • Causa
    Patterson dental is conducting a recall because they have been advised by the manufacturer of revolution formula 2 (kerr corporation) that some syringes and tips marked with the brand name are not manufactured and distributed by kerr and, thus, not authentic product.
  • Acción
    Consignees were sent a Patterson Dental "Urgent Device Recall" letter dated October 15, 2010. The letter was addressed to "Valued Customer". The letter described the product and the problem. It also advised the consignees to quarantine and return the product with the specific distribution dates. Consignees were to complete and return the enclosed Recall Return Form along with the affected product. Questions should be directed to Nancy Strand at 651-686-1966 or nancy.strand@pattersondental.com.

Device

Kerr Revolution Formula 2 Flowable Light Cure Composite
  • Modelo / Serial
    Shade A1 - Patterson Item # 434-4719;Kerr Part # 29493 Shade A2 - Patterson Item # 434-4727; Kerr Part # 29494 Shade A3 - Patterson Item # 434-4735; Kerr Part # 29495 Shade B1 - Patterson Item # 434-4768; Kerr Part # 29498
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- Including DC except VT.
  • Descripción del producto
    SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. || SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494. || SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A3, 20 - Dispensing tips, 29495. || SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes B1, 20 - Dispensing tips, 29499. || Revolution is a flowable light cure hybrid resin restorative.
  • Manufacturer
    Patterson Dental Supply, Inc.

Manufacturer

Patterson Dental Supply, Inc.
  • Dirección del fabricante
    Patterson Dental Supply, Inc., 1031 Mendota Heights Rd, Saint Paul MN 55120
  • Empresa matriz del fabricante (2017)
    Patterson Dental Supply Inc.
  • Source
    USFDA