Events

Retiro De Equipo (Recall) de Thoracic Pedicle Feeler instrument is intended for use with the Stryker Navigation System.

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 Stryker Instruments Div. of Stryker Corporation.

¿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
    79335
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1216-2018
  • Fecha de inicio del evento
    2017-10-16
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162049
  • 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
    Stryker instruments and stryker leibinger gmbh & co. kg are voluntarily recalling certain serial numbers thoracic pedicle feelers that are used in conjunction with the stryker¿ navigation system because the settings on the machine were higher than intended. this change led to increased energy directed onto the tip of the thoracic pedicle feeler which caused material degradation where the laser marks exist. there is the potential for the tip of the thoracic pedicle feeler to break.
  • Acción
    US customers will be notified via FedEx overnight. US Sales Representatives will be notified via email. International entities will be notified via an internal notification system. International customers will be notified per local regulations/procedures. Customer Instructions: Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Immediately check all stock areas and/or operating room storage for affected equipment. Quarantine and discontinue use of any affected Thoracic Pedicle Feelers. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you don't have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward this Notification and the attached BRF to all affected locations. Please indicate each location on the BRF. 5. If the BRF for your facility indicates that recalled product is currently on hand, we will contact you to arrange for the return of the product for repair/replacement. If discontinuing use of the specific Thoracic Pedicle Feeler(s) listed will cause disruption at your facility. For further questions, please call (269) 323-7700.

Device

Thoracic Pedicle Feeler instrument is intended for use with the Stryker Navigation System.
  • Modelo / Serial
    Serial Number(s) Affected: 10897, 10898, 10899, 10900, 10901, 10902, 10903, 10904, 10905, 10906, 10907, 10908, 10909, 10910, 10911, 10912, 10913, 10914, 10917, 10919, 10920, 10921, 10922, 10923, 10925, 10926, 10927, 10928. Product Code (UDI): (01)04546540503824
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International , US and US Govt.
  • Descripción del producto
    The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of || the navigation software and creation of a pathway into the pedicle. The instrument has three || types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The || Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler || tip has been inserted into the pedicle. Next to the navigational information, these depth || indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA