{
  "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": "West Chester",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86545",
      "recalling_firm": "Synthes (USA) Products LLC",
      "address_1": "1301 Goshen Pkwy",
      "address_2": "N/A",
      "postal_code": "19380-5986",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "International distribution the country of Japan Only.",
      "recall_number": "Z-0405-2021",
      "product_description": "SYNMESH 15MM DIA 88MM HEIGHT (TI)  Product Number: 495.366  - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.",
      "product_quantity": "17 units",
      "reason_for_recall": "Incorrectly Labeled  'general medical device,'  printed on the statutory label of the SYNMESH CAGE SYSTEM  instead of 'specially controlled medical device\"",
      "recall_initiation_date": "20200921",
      "center_classification_date": "20201105",
      "termination_date": "20221230",
      "report_date": "20201111",
      "code_info": "Lot Numbers:  16L1245  16L7630  42P1145  42P4281  M22"
    }
  ]
}