Events

Retiro De Equipo (Recall) de Biomet Inc., Biomet Sports Medicine, and Biomet

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
    74038
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1827-2016
  • Fecha de inicio del evento
    2016-04-01
  • Fecha de publicación del evento
    2016-05-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146050
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Insufficient seal strength on sterile barrier packaging. the seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. if the product becomes non-sterile and is used or implanted, it may lead to an infection.
  • Acción
    Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Device

Biomet Inc., Biomet Sports Medicine, and Biomet
  • Modelo / Serial
    Part #'s 900728 900737 900738 900740 909836 110008343 110009769 231201303  Lot #'s 669220 625160 625180 679060 529190 585920 742460 751280 751290 751330 751400 751410 751420 751430 630570
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
  • Descripción del producto
    Various trauma and sports medicine instruments and implants. || Orthopedic manual surgical instrument.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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