Events

Retiro De Equipo (Recall) de Device Recall Instinct Java 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 Zimmer Spine, 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
    73363
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1190-2016
  • Fecha de inicio del evento
    2016-02-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143967
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Causa
    Zimmer biomet is initiating a medical device correction notice to provide updated cleaning and disinfecting instructions for use of the instinct¿ java¿ system (ifu reference: 046wan0000t) and universal clamp¿ system (ifu reference: sna027-n-90001).
  • Acción
    Consignees were sent on 2-12-2016 a Zimmer Biomet "Urgent Medical Device Correction Notice" letter dated February 12, 2016. The letter was either addressed to Hospital Representative or to Distributors, Sales Representatives, and Distribution Operations Managers. The letters described the problem and the product involved in the recall. Advised consignees to immediately utilize the updated and attached Instructions For Use. Requested consignees to complete the "Acknowledgement of Field Notification" form. For questions contact Customer Service at 1-866-774-6368 or e-mail corporatequality.postmarket@zimmerbiomet.com.

Device

Device Recall Instinct Java System
  • Modelo / Serial
    All lots
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US (nationwide)-including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, ,MD, MA, MI, MN,MO, NV, NH, NY, NC, OH, OK,. PA, TN,TX, WA, and WI.
  • Descripción del producto
    Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . || Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.
  • Manufacturer
    Zimmer Spine, Inc.

Manufacturer

Zimmer Spine, Inc.
  • Dirección del fabricante
    Zimmer Spine, Inc., 7375 Bush Lake Rd, Minneapolis MN 55439-2027
  • 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