Events

Retiro De Equipo (Recall) de Device Recall Toggleloc 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, 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
    53878
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0559-2010
  • Fecha de inicio del evento
    2009-11-10
  • Fecha de publicación del evento
    2009-12-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86791
  • 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
    Soft Tissue Nondegradable Fixation Fastener - Product Code MBI
  • Causa
    Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.
  • Acción
    Distributors, hospital consignees and an implanting surgeon were notified of the recall by an Urgent Medical Device Recall Notice, dated 11/10/09. Distributors were instructed to locate and remove the identified products from circulation. The instructions on the enclosed "FAX Back Response Form" should be followed and product from their accounts should be returned. Hospital consignees and the implanting surgeon were informed of the recall and advised of the potential health hazards presented by the mix-up.

Device

Device Recall Toggleloc System
  • Modelo / Serial
    Lot 101780.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution -- Including states of California, Florida, South Carolina, and Virginia.
  • Descripción del producto
    Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - Titanium with Ziploop Technology, polyethylene/polypropylene/ polyester/TI-6AL-4V alloy/S.S., sterile Biomet Sports Medicine, Warsaw, IN.; REF 909853. || A smooth or threaded metallic bone fixation fastener intended to be implanted for fixation of bone fractures.
  • 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