Events

Retiro De Equipo (Recall) de Device Recall Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407266

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 Division 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
    57899
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1830-2011
  • Fecha de inicio del evento
    2011-02-03
  • Fecha de publicación del evento
    2011-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97708
  • 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
    Arthroscope - Product Code HRX
  • Causa
    The firm received five complaints that the stylet did not fit down the cannula. the investigation revealed that the incorrect probe assembly was packaged for two dekompressor part numbers with the lot number of 10214012.
  • Acción
    Stryker Instruments Division of Stryker Corporation sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 3, 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 immediately check their inventory for any recalled product and quarantine any affected product. If the product was further distributed, customers were asked to forward the letter and the completed Reply Form to all affected locations. Customers were to be contacted to coordinate return of the affected product. Upon receipt of the product, a replacement would be issued to their account. For questions regarding this recall call 1-800-253-3210.

Device

Device Recall Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407266
  • Modelo / Serial
    Lot: 10214012.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including the states of PA, NY, KS, NJ, TX, MI, OK, and FL, and the countries of Italy and Switzerland.
  • Descripción del producto
    Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407-266, Sterile, Stryker Instruments, Kalamazoo, MI. || The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation

Manufacturer

Stryker Instruments Division of Stryker Corporation
  • Dirección del fabricante
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA