Device Recall Streamline

  • Model / Serial
    Lot number: 148062, 148440
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including TX, CA, IL, and FL.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    PIONEER SURGICAL TECHNOLOGY, INC., 375 River Park Cir, Marquette MI 49855-1781
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot # JDG880205F
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Medtronic, INC., Minneapolis, MN 55432
  • Manufacturer