{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Portage",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95996",
      "recalling_firm": "Stryker Corporation",
      "address_1": "1941 Stryker Way",
      "address_2": "",
      "postal_code": "49002-9711",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.",
      "recall_number": "Z-0980-2025",
      "product_description": "The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology,  orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries.  The 3.0MM Prec Neuro Match Head bur (5820-107-530) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries.  These burs are sold as single use devices without their own IFU.",
      "product_quantity": "491 devices",
      "reason_for_recall": "There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).",
      "recall_initiation_date": "20230628",
      "center_classification_date": "20250117",
      "report_date": "20250129",
      "code_info": "GTIN 04546540362483, Lot Number 21341057",
      "more_code_info": ""
    }
  ]
}