Events

Retiro De Equipo (Recall) de Device Recall ORTHO SENSOR

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 Orthosensor.

¿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
    63081
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0122-2013
  • Fecha de inicio del evento
    2012-02-04
  • Fecha de publicación del evento
    2012-10-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112490
  • 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
    Intraoperative orthopedic joint assessment aid - Product Code ONN
  • Causa
    Ortho sensor in sunrise, fl is recalling the graphics user interface software 1.8 (which was updated to version 1.82, validated on 02/13/12). recall was initiated due to customer feedback which included the line of site between the knee ba lancer and the link station was obstructed by or metal stands or trays or the knee balancer device was placed atop of or near the metal stands or trays, interru.
  • Acción
    Orthosensor did not provide a written customer notification. As the recall was reported to the FDA well after all nine of the products were corrected (the recall stemmed from an initial inspection of the firm), then no customer notification was requested. The removal and replacement of the previous version of the Graphic User Interface Software is being handled internally by members of Operations and the Sales force. The items the firm is recalling is software, and the software cannot be returned; the old version (version 1.8) would be erased. The new version 1.82 would be installed and downloaded into the equipment at the site during servicing. This does not involve the customer of which none are consignees. Effectiveness checks associated with the update of the software is being handled internally by the Operations and the Sales force. Further questions please call (813) 645-2855.

Device

Device Recall ORTHO SENSOR
  • Modelo / Serial
    Version 1.82
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of CA, FL, MI and NY.
  • Descripción del producto
    "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" || Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. || Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.
  • Manufacturer
    Orthosensor

Manufacturer

Orthosensor
  • Dirección del fabricante
    Orthosensor, 1560 Sawgrass Corporate Pkwy, 4th Floor, Sunrise FL 33323-2858
  • Empresa matriz del fabricante (2017)
    OrthoSensor Inc.
  • Source
    USFDA