Device Recall Streamline

  • Modelo / Serial
    Lot number: 148062, 148440
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including TX, CA, IL, and FL.
  • Descripción del producto
    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.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    PIONEER SURGICAL TECHNOLOGY, INC., 375 River Park Cir, Marquette MI 49855-1781
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot # JDG880205F
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- including states of AK, AZ, CA, CO, CT, ID, IL, IN, KS, MI, MS, NE, NV, NH, NM, NY, NC, OH, OR, PA, TN, TX, VA, WA, and WI.
  • Descripción del producto
    Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Medtronic, INC., Minneapolis, MN 55432
  • Manufacturer