Events

Retiro De Equipo (Recall) de Device Recall The Cellfina System

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 Ulthera 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
    75682
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0749-2017
  • Fecha de inicio del evento
    2016-11-14
  • Fecha de publicación del evento
    2016-12-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151050
  • 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
    Powered surgical instrument for improvement in the appearance of cellulite - Product Code OUP
  • Causa
    It was discovered that a non-sterile vacuum tube is supplied within the pack, although the instructions for use (ifu) describe the use of a sterile vacuum tube as part of the procedure setup.
  • Acción
    Ulthera sent an Urgent Medical Device Recall letter dated November 15, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup. Customers are informed of the actions to be taken. Customers with any technical or logistical questions are instructed to contact technical support at Ulthera, Inc. at (480) 619-4069. The letter informs the customers with questions related to their Cellfina business are instructed to contact Merz North America at 888-751-7546 or at mymerzsolutions@merz.com.

Device

Device Recall The Cellfina System
  • Modelo / Serial
    all
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)
  • Descripción del producto
    Cellfina Prep Pack, Part No. CP1
  • Manufacturer
    Ulthera Inc

Manufacturer

Ulthera Inc
  • Dirección del fabricante
    Ulthera Inc, 1840 S Stapley Dr Ste 200, Mesa AZ 85204-6681
  • Empresa matriz del fabricante (2017)
    Merz Holding Gmbh & Co. Kg
  • Source
    USFDA