Events

Retiro De Equipo (Recall) de Device Recall TIBIO FEM/FEM NAIL

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 Zimmer, 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
    66499
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0586-2014
  • Fecha de inicio del evento
    2013-11-05
  • Fecha de publicación del evento
    2013-12-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122909
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    Based on a review of historic packaging validations, it was determined that a subset of product packaged at a zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. this testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure.
  • Acción
    On 11/5/2013, Urgent Medical Device Recall Notifications were sent to affected distributors, hospital Risk Managers, and doctors informing them of the failure. All distributors were notified via electronic mail. Hospital risk managers, surgeons and distributors with affected inventory within the expiration date of the device will also be notified via courier. The letter identifies the issue, health risks, and their responsibilities. Questions concerning the recall are directed to 1-877-946-2761 Communications outside of the United States will occur approximately two weeks after the United States communications. Zimmer will conduct effectiveness checks in the following way: Distributors/Hospitals/Surgeons 100% of the notifications will be tracked to ensure delivery of the notifications. An inventory certification form will need to be returned from each distributor that certifies that all available affected product from their territory has been returned. Additional notifications via email and FedEx will be sent to those who have not completed the required certification form or returned affected product. Accounts will be deemed unresponsive after 3 attempts.

Device

Device Recall TIBIO FEM/FEM NAIL
  • Modelo / Serial
    Item Numbers 32-8553-311-11 32-8553-311-13 32-8553-311-15 32-8553-311-17 All lots with an expiration date prior to July 24, 2023
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    TIBIO FEM/FEM NAIL.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA