{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Schaumburg",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69471",
      "recalling_firm": "Instrumed International, Inc.",
      "address_1": "626 Cooper Ct",
      "address_2": "N/A",
      "postal_code": "60173-4537",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.",
      "recall_number": "Z-0549-2015",
      "product_description": "Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.",
      "product_quantity": "3 Galt trephines",
      "reason_for_recall": "The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",
      "recall_initiation_date": "20140908",
      "center_classification_date": "20141208",
      "termination_date": "20171129",
      "report_date": "20141217",
      "code_info": "1) Instrumed Product Name: Galt Trephine, 5/8\"; Instrumed Product Number: 600-01091; Trade Name: CareFusion; CareFusion Product Name: Galt Trephine, 5/8\"; CareFusion Item Number: VM85-1273; Lot Number: 120411."
    }
  ]
}