Events

Retiro De Equipo (Recall) de Device Recall Microplasty Elite Instruments Vanguard Femoral Cutting Blocks

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 Biomet, 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
    50698
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0879-2009
  • Fecha de inicio del evento
    2008-12-18
  • Fecha de publicación del evento
    2009-01-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76187
  • 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
    Manual Surgical Instrument for General Use - Product Code HTZ
  • Causa
    Falling component: the universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
  • Acción
    Consignees were notified by letter entitled "URGENT MEDICAL DEVICE REMOVAL NOTICE" dated 12/18/08 advising them of the problem and that the instruments should be removed from use and returned. For further information, please contact Biomet, Inc., by telephone on 800-348-9500.

Device

Device Recall Microplasty Elite Instruments Vanguard Femoral Cutting Blocks
  • Modelo / Serial
    Lots 084400 and 132802.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
  • Descripción del producto
    Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 70 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485156. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 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