Events

Retiro De Equipo (Recall) de Total Temporomandibular Joint Replacement 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 Biomet Microfixation, LLC.

¿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
    67547
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2566-2014
  • Fecha de inicio del evento
    2013-09-20
  • Fecha de publicación del evento
    2014-09-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125711
  • 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
    Joint, temporomandibular, implant - Product Code LZD
  • Causa
    Product mix occurred prior to final package and labeling process.
  • Acción
    Biomet Microfixation, Inc. sent an Urgent Medical Device Field Notice dated September 20, 2013 to its customer. The customer was instructed to: 1) Immedicately quarantine the device. 2) Discontinue use and return to Biomet Microfixation. 3) If the product was further distributed, the letter must be forwarded to the firm's customers. 4) A replacement device will be shipped priority upon completion. Questions related to this notice should be directed to 904-741-9448 or 904-239-6671. For questions regarding this recall call 904-741-4400.

Device

Total Temporomandibular Joint Replacement System
  • Modelo / Serial
    Part #CP751506 Lot #478490
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution to Denmark only.
  • Descripción del producto
    Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 || The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.
  • Manufacturer
    Biomet Microfixation, LLC

Manufacturer

Biomet Microfixation, LLC
  • Dirección del fabricante
    Biomet Microfixation, LLC, 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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