Events

Retiro De Equipo (Recall) de Device Recall Osteobond Copolymer Bone Cement

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 Zimmer, 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
    69904
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0900-2015
  • Fecha de inicio del evento
    2014-12-08
  • Fecha de publicación del evento
    2014-12-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131930
  • 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
    Bone cement - Product Code LOD
  • Causa
    Samples of product from supplier lot 14d0809 and 14d0808 showed little adhesive transfer between the tyvek lid and cavity when opened for internal bone cement cure and pairing tests. visually these samples do not meet the requirements of zwi 43.109 and corresponding visual aid 55-0000-310-01.
  • Acción
    "Urgent Medical Device Recall - Lot Specific" notifications will be sent to the affected distributors, surgeons, and hospital risk managers with instructions for returning the affected product. The letters identified the affected product, reason for recall, risks, and responsibilities. Customers are to complete and return the Inventory Return Certification Form along with the affected product. Questions should be directed to the customer call at 1-800-348-2759.

Device

Device Recall Osteobond Copolymer Bone Cement
  • Modelo / Serial
    PMA #N17755, decision date 5/17/1976, reclassified 10/14/1999. Class II device; D033511, Item No. 00-1101-012-00; lot 62849791, 14D0809, Manufactured between 9/11/2014-10/6/2014; EXP date: 4/30/2017
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed to MI, KS, and CA.
  • Descripción del producto
    Osteobond Bone Cement || Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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