{
  "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": "Completed",
      "city": "Portage",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95040",
      "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 Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom.",
      "recall_number": "Z-2725-2024",
      "product_description": "Stryker iBur 3.0mm Diamond Round, Distal Bend -  intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications  Ref: 8431-012-030D",
      "product_quantity": "2507 units",
      "reason_for_recall": "Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.",
      "recall_initiation_date": "20240724",
      "center_classification_date": "20240826",
      "report_date": "20240904",
      "code_info": "GTIN: 7613327501230 Lot Numbers: 22216017 22230017 22334017 23004017 23004027 23009017 23157017 23208017 23233017 23233027 24003017",
      "more_code_info": ""
    }
  ]
}