Events

Retiro De Equipo (Recall) de Device Recall IMPAK Liquid Acrylic Resin

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 CMP Industries, Llc.

¿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
    73629
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2089-2016
  • Fecha de inicio del evento
    2016-03-02
  • Fecha de publicación del evento
    2016-06-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144626
  • 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
    Resin, denture, relining, repairing, rebasing - Product Code EBI
  • Causa
    Possible presence of foreign material (rust).
  • Acción
    CMP Industries/Nobilium sent an Urgent IMPAK Recall letter dated March 2, 2016, to all affected customers via certified mail with return receipt in an attempt to verify if customers were in possession of the affected product. Customers were advised to immediately examine inventory and to quarantine product subject to the recall. In addition, if customers further distributed the product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of the notice. If customers have any of the product in their posession subject to recall, please contact the firm by calling 518-434-3147, ext 144, Monday - Friday 8-4:30 pm, EST.

Device

Device Recall IMPAK Liquid Acrylic Resin
  • Modelo / Serial
    Lot Number 101113
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA
  • Descripción del producto
    IMPAK Liquid Acrylic Resin sold under the following labels: || 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 || 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 || 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 || 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, || 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 || Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base
  • Manufacturer
    CMP Industries, Llc

Manufacturer

CMP Industries, Llc
  • Dirección del fabricante
    CMP Industries, Llc, 413 N Pearl St, Albany NY 12207-1311
  • Empresa matriz del fabricante (2017)
    CMP Industries, Llc
  • Source
    USFDA