Events

Retiro De Equipo (Recall) de Device Recall Xpress System Pedicle Screw Assembly, 5.5 x 55mm

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
    70774
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1512-2015
  • Fecha de inicio del evento
    2015-03-11
  • Fecha de publicación del evento
    2015-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134646
  • 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
    Orthosis, spondylolisthesis spinal fixation - Product Code MNH
  • Causa
    One lot of instruments have etched on the yoke of the pedicle screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
  • Acción
    The firm, X-spine Systems, Inc., sent an "Urgent Medical Device Recall" letter dated March 19, 2015 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to notify affected hospital and surgeon of the recall immediately; complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately via mail: 725 Alexandersville Road, Miamisburg OH 45342-RMA #5288; and No action should be taken with product that has been implanted. Please contact customer service at 800.903.0640 or email orders@x-spine.com with any questions.

Device

Device Recall Xpress System Pedicle Screw Assembly, 5.5 x 55mm
  • Modelo / Serial
    Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to states of: KS, NV & TX.
  • Descripción del producto
    Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
  • 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