Events

Retiro De Equipo (Recall) de Device Recall Artificial ligament fixation device

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
    55776
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1952-2010
  • Fecha de inicio del evento
    2010-03-31
  • Fecha de publicación del evento
    2010-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91755
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Causa
    The firm has received complaints that the saddle is too long. the saddle is supposed to be between 7/8 and 1 1/8 inches long. the saddle in the complaints was up to 1.9 inches long.
  • Acción
    Biomet Sports Medicine issued an "Urgent Medical Device Recall Notice" dated March 31, 2010 to user facilities and distributors. A second notification containing updated information was issued June 2, 2010. Consignees were instructed to discontinue use of the product and return it to the firm along with a completed Response Form. For further information, contact Biomet at 1-574-371-3755 or 1-574-371-3756, Monday through Friday, 8AM to 5PM.

Device

Device Recall Artificial ligament fixation device
  • Modelo / Serial
    Lot Numbers: 047510, 050400, 050420, 089710, 089800, 182820, 192240, 192250, 192280, 219260, 219270, 219280, 228530, 228550, 228580, 228590, 228610, 228620, 295450, 361020, 361020, 392930, 392990, 483490, 483500, 529380, 527780, 529800, 529810, 582890, 582910, 627510, 648470, 648480, 671130, 671150, 671170, 671180, 671190, 671240, 706150, 706160, 782360, 782370, 821710, 821730, 943000, 943010, 943030, 952040, 952070 and 974140.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- United States, Canada, Australia, The Netherlands, Belgium, Italy, France, New Zealand, Austria, United Kingdom, Chile, Greece, Poland, Denmark, Turkey, Portugal, South Africa and Spain.
  • Descripción del producto
    Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755, Biomet Sports Medicine Warsaw, IN. || Intended for soft tissue to bone fixation.
  • 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