{
  "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": "Medina",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "54725",
      "recalling_firm": "Orthohelix Surgical Designs Inc",
      "address_1": "1065 Medina Rd., Suite 500",
      "address_2": "N/A",
      "postal_code": "44256",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI.",
      "recall_number": "Z-0027-2013",
      "product_description": "OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE  MAT: 465 SS    The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.",
      "product_quantity": "120 Pieces",
      "reason_for_recall": "The tips of the drivers are breaking while being used to drive the screws into patients.",
      "recall_initiation_date": "20100129",
      "center_classification_date": "20121009",
      "termination_date": "20130220",
      "report_date": "20121017",
      "code_info": "HSC-056-38-1067061"
    }
  ]
}