FDAFDA · Alimentos y medicamentos·N.º oficial Z-2616-2014
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
Publicado el 17 de septiembre de 2014 · Inicio del retiro: 14 de junio de 2013
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
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- PIONEER SURGICAL TECHNOLOGY, INC.
- Distribuidor
- Nationwide Distribution including TX, CA, IL, and FL.
- Lote
- Lot number: 148062, 148440
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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