Events

Retiro De Equipo (Recall) de Device Recall Spineology Fill Tube, diverted

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 The Spineology Group.

¿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
    31198
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0677-05
  • Fecha de inicio del evento
    2005-01-28
  • Fecha de publicación del evento
    2005-04-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37352
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Causa
    Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. fill tubes are used in delivery of bone graft materials.
  • Acción
    A Product Update, January 2005 (Vol. 2) was e-mailed to all representatives and also sent by mail on January 28, 2005. Telephone calls to each distributor/representative were made by Spineology Sales & Marketing staff between January 28 and January 31. The Product Update informs customers that they will be receiving new tubes and new platens soon and that any tubes and platens currently in their possession should be returned to Spineology.

Device

Device Recall Spineology Fill Tube, diverted
  • Modelo / Serial
    Lot # UN02002, 71-1057, UN04003 and UN04004
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    11 consignees located in: Arkansas, Arizona, California, Georgia, Illinois, Michigan, Minnesota, North Carolina, New York, Oklahoma and United Kingdom
  • Descripción del producto
    Fill Tube,diverted, Catalog # 300-1002, is used for the delivery of granular autograft or allograft into Spineology''s OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto the metal.
  • Manufacturer
    The Spineology Group

Manufacturer

The Spineology Group
  • Dirección del fabricante
    The Spineology Group, 1815 Northwestern Ave S, Stillwater MN 55082-6500
  • Source
    USFDA