Events

Retiro De Equipo (Recall) de Navitrack System OS Knee Universal, Stereotaxic instrument

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 Orthosoft, Inc. dba Zimmer CAS.

¿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
    75613
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2076-2017
  • Fecha de inicio del evento
    2008-10-28
  • Fecha de publicación del evento
    2017-05-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154873
  • 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
    Neurological stereotaxic Instrument - Product Code HAW
  • Causa
    Zimmer cas voluntarily conducted a retrospective recall of the navitrack system os knee universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, d.54 and a.42 due to software issues resulting in erros and discrepancies .
  • Acción
    This is a retrospective report of a correction taken on 28 October, 2008. The software issues mentioned above were corrected in subsequent software updates. There were 153 units of the affected software distributed. There were 147 of the 153 units confirmed to have installed the updated software per the correction notice for a total percentage of 96%. Recall Notices were sent to customers on 10/28/2008.

Device

Navitrack System OS Knee Universal, Stereotaxic instrument
  • Modelo / Serial
    Part Number, Lot Number/Serial Number ORTHOsoft-UniTkr- 2.2.0.82, 2.2.1.3 ORTHOsoft-UniTkr- 2.1.6.0.2 OsUniTkr (previous naming convention for ORTHOsoft-UniTkr)- D.54, A.42
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Domestic: CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA Foreign: Canada, Australia Austria Brazil China Czech Republic France Germany Israel Italy Lebanon Luxembourg Netherlands New Zealand Spain Sweden Switzerland United Kingdom
  • Descripción del producto
    Navitrack System - OS Knee Universal, Stereotaxic instrument
  • Manufacturer
    Orthosoft, Inc. dba Zimmer CAS

Manufacturer

Orthosoft, Inc. dba Zimmer CAS
  • Dirección del fabricante
    Orthosoft, Inc. dba Zimmer CAS, 75 Queen St #3300, Montreal Canada
  • 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