{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Bedford",
      "address_1": "28 Crosby Dr",
      "reason_for_recall": "iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).",
      "address_2": "",
      "product_quantity": "1 unit",
      "code_info": "Serial Number: 0384180",
      "center_classification_date": "20170110",
      "distribution_pattern": "Distribution to TX only",
      "state": "MA",
      "product_description": "ConFORMIS  ITOTAL PS-IPOLYIMPLANT KIT-RIGHT  Catalog Number:TPS-111-1111  The iTotal¿ PS 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",
      "report_date": "20170118",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "ConforMIS, Inc.",
      "recall_number": "Z-0991-2017",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "75969",
      "termination_date": "20170111",
      "more_code_info": "",
      "recall_initiation_date": "20161031",
      "postal_code": "01730-1402",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}