Events

Retiro De Equipo (Recall) de Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve

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
    49709
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0288-2009
  • Fecha de publicación del evento
    2008-11-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74060
  • 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
    Fixation Cerclage - Product Code JDQ
  • Causa
    The outer package is properly labeled, but the inner package may be labeled as a femoral component.
  • Acción
    The firm's sales force was notified of the problem via an Urgent Medical Device Removal Notice letter dated 9/24/08, and provided instructions to retrieve the product from customer accounts and to provide them with a copy of the removal letter. Distributors were to immediately locate and remove the identified implants from circulation, carefully follow the instructions, and fax a copy of the Response Form prior to the return of the product. If the product was further distributed, hospital personnel MUST be notified via the enclosed "Dear Biomet Customer" notice. The letter MUST be given to hospital personnel responsible for receiving recall notices but distributors are charged with the location and return of those products.

Device

Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve
  • Modelo / Serial
    Lot 568400.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution --- USA including states of Arkansas, Florida, Kansas, New Jersey, and Ohio, and countries of Argentina, Canada, Chile Italy, Mexico and United Kingdom.
  • Descripción del producto
    Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet Orthopedics, Inc., Warsaw, IN; REF. 350805. || Intended for general orthopedic repairs including long bone fractures, bone grafting, reinforcement of bone and reattachment of the greater trochanter.
  • 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