{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Addison",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85516",
      "recalling_firm": "Skeletal Kinetics, Llc",
      "address_1": "3885 Arapaho Rd",
      "address_2": "N/A",
      "postal_code": "75001-4314",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the state of Florida.",
      "recall_number": "Z-2054-2020",
      "product_description": "Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger than 25cm2. CRANIO/SCULPT C may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.",
      "product_quantity": "125 units",
      "reason_for_recall": "Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.",
      "recall_initiation_date": "20200403",
      "center_classification_date": "20200520",
      "termination_date": "20250130",
      "report_date": "20200527",
      "code_info": "Lot 1129289"
    }
  ]
}