Events

Retiro De Equipo (Recall) de Zimmer Trabecular metal Modular Acetabular 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 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
    56651
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0060-2011
  • Fecha de inicio del evento
    2010-08-18
  • Fecha de publicación del evento
    2010-10-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94181
  • 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
    prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Causa
    The threads on the device were not completely machined and therefore would not mate with athe corresponding cup positioner/shell inserter.
  • Acción
    The firm, Zimmer, made telephone calls using a phone script document entitled "Urgent: Medical Device Recall" Phone Script Call Communication, to the customers that received this product starting on 8/18/2010. The telephone calls were to determine the status of the recalled product. A Zimmer Field Action Strategy notification dated August 9, 2010 was also provided. The notifications/phone script described the product, problem and actions to be taken by the customers. The customers were instructed to remove the 00-6202-056-22, lot 61091653 product from their inventory and return to Zimmer Product Service Department, Attn: Product Service, 1777 West Center Street, Warsaw, IN 45680. Note: If the product had been used, no action was necessary. The returned product will be evaluated to determine how many of the devices had the defect. If you have any questions, please call (574) 371-8852.

Device

Zimmer Trabecular metal Modular Acetabular system
  • Modelo / Serial
    61091653
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution:USA including states of: MI, IN, WI, MO, CA, VA, MD, TX, NC, PA, OR, WA, FL, GA, NY, ME, AZ, and UT and country including Canada.
  • Descripción del producto
    Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog 00-6202-056-22, Zimmer Inc., Warsaw, IN. || This device is indicated for primary or revision surgery for rehabilitating hips damaged as the result of noninflammatory degenerative joint disease, including osteoarthritis, fused hip, avascular necrosis, traumatic arthritis and fracture of the pelvis.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Dirección del fabricante
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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