FDAFDA · Alimentos y medicamentos·N.º oficial Z-0413-2013
CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
Publicado el 28 de noviembre de 2012 · Inicio del retiro: 20 de septiembre de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Qué hacer
Voluntary: Firm initiated · Other
Detalles del retiro
- Fabricante
- Captiva Spine, Inc
- Distribuidor
- Nationwide Distribution (Distributed to one customer located in MN)
- Lote
- Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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