Events

Retiro De Equipo (Recall) de Device Recall Navigation System IICart with Articulated Arm Camera

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
    71268
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1810-2015
  • Fecha de inicio del evento
    2015-05-04
  • Fecha de publicación del evento
    2015-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137176
  • 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 initiated a device recall of the navigation system ii-cart, camera articulated arm because there is a potential that the weld seam between the main stud and the two flaps on the articulated arm was not welded in the correct location, which may result in a potential failure of the arm joint.
  • Acción
    Stryker sent an Urgent Medical Device Recall Notification letter dated May 18, 2013 to Domestic customers notice via FedEx overnight and Sales Representatives via email. The International Subsidiaries will also be notified via email. Customers are instructed to immediately review the Recall Notification adn complete the following: Immediately check all stock areas and/or operating room storage for affected equipment found. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many affected items are currently in inventory. Please complete and return the BRF even if they dont have any affected product on hand. If customers have further distributed this product, they are asked to forward this letter and the attached BRF to all affected locations. Please indicate each location and serial number(s) on the BRF. Fax (866-521-2762) or email (kellyjo.davis@stryker.com) the completed BRF to Stryker Instruments Regulatory Department, Attn: Kelly Jo Davis. A Stryker Representative will contact the facility to set up a time to perform the additional inspection of the weld seam on the Navigation System II-Cart, Articulated Arm Camera.

Device

Device Recall Navigation System IICart with Articulated Arm Camera
  • Modelo / Serial
    Serial numbers 100019, 100984, 100965, 100295, 100979, 100773, 100946, 100797, 100947, 100956, 100966, 100649, 100967, 100944, 100941, 100945, 100970, 100950, 100976, 100951, 100728, 100952, 100248, 100953, 100641, 100954, 100463, 100955, 100981, 100957, 100978, 100958, 100106, 100959, 100939, 100960, 100973, 100961, 100236, 100962, 100237, 100963, 100417, 100964. 100940, 100968, 100975, 100969, 100977, 100972, 100105, 100974, 100214, 100980, 100492, 100982, 100493, 100983, 100948, 100986, 100704, 100987, 100949, 100988, 100227, 100989, 100971, 100133, 100134, 100942.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of AR, CO, FL, GA, IN, KS, KY, MA, MI, NC, NE, NJ, NY, OH, OK, PA, TX, WA, WY and the countries of Canada, Europe, and Asia.
  • Descripción del producto
    Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U || Product Usage: || The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.
  • 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