{
  "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": "Billerica",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82100",
      "recalling_firm": "Conformis, Inc.",
      "address_1": "600 Technology Park Dr",
      "address_2": "N/A",
      "postal_code": "01821-4154",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the state: NC and the country of:  Hungary.",
      "recall_number": "Z-1108-2019",
      "product_description": "iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.)  M5725INT0600010 (Model No.)    Product Usage:  The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.",
      "product_quantity": "2",
      "reason_for_recall": "The kits were prepared with incorrect patient ID labels and may contain incorrect components.",
      "recall_initiation_date": "20181203",
      "center_classification_date": "20190408",
      "termination_date": "20200626",
      "report_date": "20190417",
      "code_info": "Serial Numbers 0432428 and 0432212"
    }
  ]
}