Events

Retiro De Equipo (Recall) de Device Recall NexGen Complete Knee Solution

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
    65413
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2005-2013
  • Fecha de inicio del evento
    2013-06-07
  • Fecha de publicación del evento
    2013-08-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118824
  • 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
    Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
  • Acción
    Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany. " Communications outside of the United States will occur approximately two weeks after the United States communications.

Device

Device Recall NexGen Complete Knee Solution
  • Modelo / Serial
    all codes
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) and the country of Japan.
  • Descripción del producto
    00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; || 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; || 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; || 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx, Sterile; || 00597104120 Provisional CR ART SURF PROV 56/STR GRN 20, Rx, Sterile; || 00597104123 Provisional CR ART SURF PROV 56/STR GRN 23, Rx, Sterile; || Used in total knee arthroplasty and indicated for patients with severe pain.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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