Events

Retiro De Equipo (Recall) de Device Recall Maxcem Elite, a dental cement

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
    60685
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0915-2012
  • Fecha de inicio del evento
    2011-02-03
  • Fecha de publicación del evento
    2012-01-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106203
  • 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 w/out zinc-oxide eugenol as an ulcer covering for pain relief - Product Code MZW
  • Causa
    The recall was initiated because kerr corporation has confirmed that the use of the affected lot of maxcem elite may not provide users with a minimum of 2 minutes of work¿time thereby causing the product to prematurely set by 15 seconds.
  • Acción
    Kerr Corporation sent a Urgent Medical Device Recall letter dated March 14, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It has recently come to our attention that use of the affected lot of product may not provide users with a minimum of 2 minutes of work¿time thereby causing the product to prematurely set by 15 seconds. If this were to happen prior to placing restorations on the tooth or core build-up the restorations may not adhere properly. If you have any of the affected product listed above please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit. Please fax back the enclosed Recall Return Form in order to confirm your receipt of this recall notification regardless of whether you have any product in your inventory.

Device

Device Recall Maxcem Elite, a dental cement
  • Modelo / Serial
    Lot Number 3360900
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) and the countries of Canada, Australia and New Zealand.
  • Descripción del producto
    Brand name: Maxcem Elite, || Product: a dental cement, || Part Number: 34418. || The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants
  • 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