Events

Retiro De Equipo (Recall) de Spinal Invervetebral Disc Space Orthosis

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 Captiva Spine, 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
    61925
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1786-2012
  • Fecha de inicio del evento
    2012-04-27
  • Fecha de publicación del evento
    2012-06-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109506
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Causa
    Captiva spine, inc. initiated a recall of fuselox lumbar implants, trials, and inserters after fda advised the firm that there is inadequate support for implemented design changes to the cleared device pivotec lumbar interbody fusion device.
  • Acción
    Captiva Spine sent a Voluntary Correction Notification letter dated May 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and return affected devices. Customers were also instructed to complete and return a Tracking/Verification Form. For questions customers were instructed to call 877-772-5571. For questions regarding this recall call 561-277-9480.

Device

Spinal Invervetebral Disc Space Orthosis
  • Modelo / Serial
    Lot Number: 6110100.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    USA (nationwide) including FL,TX, UT, and NJ.
  • Descripción del producto
    Accessories for the Captiva Spine FuseLOX Lumbar Cage. || The FuseLOX Lumbar Inserter product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. || Inserter products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. || FPT - F is FuseLOX, P is Plif, and I is Inserter. || Products subject to recall: FuseLOX Lumbar Inserter || Inserter - Part Number: FPT0200 Lot Number 6110100. || Quantity distributed (8) is found in table on page 5 of 6. || The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
  • Manufacturer
    Captiva Spine, Inc

Manufacturer

Captiva Spine, Inc
  • Dirección del fabricante
    Captiva Spine, Inc, 967 Alternate A1A, Suite1, Jupiter FL 33477
  • Empresa matriz del fabricante (2017)
    Captiva Spine Inc.
  • Source
    USFDA