Events

Retiro De Equipo (Recall) de BruxZir Shaded

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 Prismatik Dentalcraft, 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
    75082
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2897-2016
  • Fecha de inicio del evento
    2016-08-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149325
  • 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
    Powder, porcelain - Product Code EIH
  • Causa
    Prismatik dentalcraft is recalling bruxzir shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. prismatik failed to properly identify the lots as quarantined product.
  • Acción
    Prismatik DentalCraft, Inc. sent an Urgent Medical Device Recall letter dated August 15, 2016, to all their customers to inform them that Prismatik Dentalcraft is recalling BruxZir NOW product because the new design was manufactured at risk and was supposed to be quarantined and held until validation was completed. Prismatik failed to properly identify the implicated lots as quarantined product. Customers are informed that the BruxZir Now with the thicker sprue design was packaged and shipped to customers in error. Customers are informed of that there is no risk to the patient and of the actions to be taken for the customers and from Prismatic Dentalcraft Inc. For questions regarding this recall call 949-440-2600.

Device

BruxZir Shaded
  • Modelo / Serial
    BZ0004415  BZ0004745  BZ0004416  BZ0004747  BZ0004522  BZ0004360  BZ0004496  BZ0004593  BZ0004094  BZ0004614
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
  • Descripción del producto
    BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 || The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
  • Manufacturer
    Prismatik Dentalcraft, Inc

Manufacturer

Prismatik Dentalcraft, Inc
  • Dirección del fabricante
    Prismatik Dentalcraft, Inc, 2181 Dupont Dr, Irvine CA 92612-1301
  • Empresa matriz del fabricante (2017)
    Prismatik Dentalcraft, Inc
  • Source
    USFDA