Events

Retiro De Equipo (Recall) de Shoulder humeral tray

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
    58571
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2546-2011
  • Fecha de inicio del evento
    2011-04-22
  • Fecha de publicación del evento
    2011-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99804
  • 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, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
  • Causa
    The firm is initiating this recall following an investigation which identified the rare possibility that certain units of comprehensive reverse shoulder humeral trays may contain a locking ring that is incorrectly assembled.
  • Acción
    The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580. Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.

Device

Shoulder humeral tray
  • Modelo / Serial
    M223830 and M699350.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide) including: Puerto Rico and countries including: Australia, Canada, Chile, Columbia, Costa Rica, Korea and Netherlands.
  • Descripción del producto
    Custom bi-angular to reverse shoulder humeral tray 44 mm sterile, REF CP561548, Biomet Orthopedics, Warsaw, IN. || Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
  • 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