{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Beverly",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "64984",
      "recalling_firm": "SpineFrontier, Inc.",
      "address_1": "500 Cummings Ctr Ste 3500",
      "address_2": "N/A",
      "postal_code": "01915-6516",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Distribution only in Texas.",
      "recall_number": "Z-1926-2013",
      "product_description": "Rev E PedFuse Return Screw Inserter, Part Number:  11-80030    Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .",
      "product_quantity": "8",
      "reason_for_recall": "Inserters have a set screw that fixes a collar to the inserter.  The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter.  When the collar is not in place the locking sleeve can also slide off the inserter.",
      "recall_initiation_date": "20130314",
      "center_classification_date": "20130808",
      "termination_date": "20150603",
      "report_date": "20130814",
      "code_info": "Lot Number:  PM3979"
    }
  ]
}