{
  "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": {
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  "results": [
    {
      "country": "United States",
      "city": "Burlington",
      "address_1": "1 North Ave",
      "reason_for_recall": "Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique",
      "address_2": "Suite B",
      "product_quantity": "1427 units",
      "code_info": "All serial numbers",
      "center_classification_date": "20120817",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the country of  Germany",
      "state": "MA",
      "product_description": "Conformis iTotal CR-Cruciate Retaining Knee Replacement System   Model Numbers:  M57250600010   iTotal CR, Left Knee  M57250600020 iTotal CR, Right Knee    Product Usage :  Usage:  The iTotal CR Knee Replacement System (KRS) 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, patello-femoral or bi-compartmental prosthesis.",
      "report_date": "20120829",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Conformis Inc",
      "recall_number": "Z-2222-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62576",
      "termination_date": "20130227",
      "recall_initiation_date": "20120717",
      "postal_code": "01803-3305",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
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}