{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Marquette",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69036",
      "recalling_firm": "PIONEER SURGICAL TECHNOLOGY, INC.",
      "address_1": "375 River Park Cir",
      "address_2": "N/A",
      "postal_code": "49855-1781",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide Distribution including TX, CA, IL, and FL.",
      "recall_number": "Z-2616-2014",
      "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.",
      "product_quantity": "9",
      "reason_for_recall": "The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.",
      "recall_initiation_date": "20130614",
      "center_classification_date": "20140909",
      "termination_date": "20140930",
      "report_date": "20140917",
      "code_info": "Lot number: 148062, 148440"
    }
  ]
}