Events

Retiro De Equipo (Recall) de Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat

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
    68457
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1932-2014
  • Fecha de inicio del evento
    2014-05-19
  • Fecha de publicación del evento
    2014-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127982
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
  • Acción
    Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.

Device

Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, P...
  • Modelo / Serial
    Size 2, includes the following Lot numbers: 37214650 61417415 61417416 61442278 61459938 61459939 61459940 61488069 61497510 61497511 61518148 61518149 61538023 61543972 61543973 61543974 61567335 61592049 61592050 61627189 61627190 61672554 61672555 61672556 61672557 61672558 61682128 61682129 61721665 61721666 61721667 61774118 61774119 61774120 61827109 61827110 61827111 61863080 61863081 61863083 61863084 61863085 61912434 61915370 61915371 61979021 61979022 61979023 62016175 62020276 62041296 62060610 62069533 62091728 62141255 62141256 62141257 62155305 62155306 62155307 62177111 62214660 62214661 62214662 62214663 62214664 62251565 62251566 62271420 62298567 62315723 62319301 62326315 62337922 62337923 62345561 62345562 62377649 62383365 62411732 62411733 62411735 62411736 62411737 62586465 62586467 62610913 62610914 62640980 62646141 62646142
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
  • Descripción del producto
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
  • 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