Events

Retiro De Equipo (Recall) de Device Recall NanoTips

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 Ultradent Products, 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
    76039
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1034-2017
  • Fecha de inicio del evento
    2016-12-14
  • Fecha de publicación del evento
    2017-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152022
  • 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
    Syringe, restorative and impression material - Product Code EID
  • Causa
    Ultradent products, inc. announces a voluntary field action for the nanotips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe.
  • Acción
    Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated December 14, 2016, to all affected consignees. The letter instructed consignees to discard remaining inventory and return the response form. For any questions, please call at 801-553-4858.

Device

Device Recall NanoTips
  • Modelo / Serial
    Lot Numbers: BD6KM, BCVPG, BCTBY, BD3K4, BCWVZ
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide) - Internationally to Belgium, Switzerland, Germany, Italy, South Korea, Netherlands, and Japan.
  • Descripción del producto
    NanoTips 30g 20pk, 100pk PN 1240, 1426 || Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and 0.488 in length. The cannula is secured in the base with an epoxy adhesive. Indications: Tips, when used in conjunction with the range of available syringes and products, provide a technique that is designed to provide a faster, easier, and more precise delivery. They are designed and created in such a way to generate less product waste and provide optimum control/leverage. Tips are also used for moisture removal and for directing laser light beam. Each of the tips is part of delivery systems designed for dentist-supervised, intra-oral procedures. The NanoTIp is designed for use with dental products manufactured by Ultradent Products, Inc. such as: UltraSeal XT¿ plus, UltraSeal XT¿ hydro, Ultra-Etch¿, PermaFloIdeal for microscopic restorative dentistry
  • Manufacturer
    Ultradent Products, Inc.

Manufacturer

Ultradent Products, Inc.
  • Dirección del fabricante
    Ultradent Products, Inc., 505 W 10200 S, South Jordan UT 84095-3800
  • Empresa matriz del fabricante (2017)
    Ultradent Products Inc
  • Source
    USFDA