Events

Retiro De Equipo (Recall) de Device Recall SpineWave

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 Spine Wave, 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
    71497
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1960-2015
  • Fecha de inicio del evento
    2015-05-04
  • Fecha de publicación del evento
    2015-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137960
  • 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
    Stimulator, nerve - Product Code ETN
  • Causa
    Mislabeled outer carton: monopolar probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm.
  • Acción
    Spine Wave sent an Urgent: Medical Device Recall letter dated June 11, 2015 to affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to acknowledge receipt of notification by returning the enclosed Recall Notice Acknowledgement Form in the stamped envelope provided. For questions, contact Spine Wave directly at 203-944-9494 and ask for the Recall Coordinator or by email at rsmith@spinewave.com.

Device

Device Recall SpineWave
  • Modelo / Serial
    Lot Codes: 092514Z, 120814A, 011415H and 022415F
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the state of CA, FL, GA, LA, MA, MD, MI, MO, NC, NH, OH, OR, PA, TX, and VA.
  • Descripción del producto
    Spine Wave Access Kit, Catalog Number 10-1530 || Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. || Product Usage: || The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
  • Manufacturer
    Spine Wave, Inc.

Manufacturer

Spine Wave, Inc.
  • Dirección del fabricante
    Spine Wave, Inc., 3 Enterprise Dr Ste 302, Shelton CT 06484-4694
  • Empresa matriz del fabricante (2017)
    Spine Wave Inc
  • Source
    USFDA