Events

Retiro De Equipo (Recall) de Device Recall Axle Interspinous Fusion System Torque Driver Handle

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 X Spine Systems 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
    59756
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0034-2012
  • Fecha de inicio del evento
    2011-07-15
  • Fecha de publicación del evento
    2011-10-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103598
  • 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
    General and plastic surgery - Product Code FZS
  • Causa
    The firm learned that the torque driver handles were not actuating at a proper torque. it was determined that the handles were speed determinant and could output a higher torque if the handles were turned at a very slow speed.
  • Acción
    X-spine Systems, Inc. sent an URGENT DEVICE RECALL letter dated September 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their stock immediately to determine if they have any affected product. If so, customers were instructed once the set screw is tightened onto the locking plate, and resistance is detected in the handle, it will take less than 2 seconds to hear the handle "click." The "click" indicates the torque limit was reached. If further resistance is felt after 2 seconds, the surgeon should release the handle from tension, and try again. If the product was distributed further, they should contact their accounts, and advise them of this recall. The firm will send replacement handles. For any questions call (937) 847-8400, ext 115.

Device

Device Recall Axle Interspinous Fusion System Torque Driver Handle
  • Modelo / Serial
    Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT.
  • Descripción del producto
    Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 || The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
  • Manufacturer
    X Spine Systems Inc

Manufacturer

X Spine Systems Inc
  • Dirección del fabricante
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • Empresa matriz del fabricante (2017)
    X-Spine Systems, Inc
  • Source
    USFDA