Events

Retiro De Equipo (Recall) de TM Ardis Interbody System Inserter

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
    63559
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0659-2013
  • Fecha de inicio del evento
    2012-09-20
  • Fecha de publicación del evento
    2013-01-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114205
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Causa
    Zimmer spine is has received complaints of difficulty in turning the implant release knob of the tm ardis inserter after final positioning of the tm ardis interbody spacer implant. there has been two reports where the inserter instrument was inadvertently removed from patient with the implant still engaged. the correction includes revised directions explaining the technique to remove the implant.
  • Acción
    Zimmer sent a "MEDICAL DEVICE CORRECTION" letter dated September 26, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Risk Manager Confirmation Form was attached for customers to complete and return. Questions and concerns should be addressed to Zimmer Spine Customer Service at 866-774-6368. When re-design is approved, Zimmer will remove and replace all affected devices.

Device

TM Ardis Interbody System Inserter
  • Modelo / Serial
    Part number: 96-701-10001; Lot numbers: 61946711, 61946712, 61991588, 62000412,
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    USA nationwide; Europe, Sweden
  • Descripción del producto
    The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. || The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.
  • 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