{
  "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": "85108",
      "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": "Telephone",
      "distribution_pattern": "US Nationwide distribution in the states of LA, NY, TN.",
      "recall_number": "Z-1627-2020",
      "product_description": "iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - 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": "4",
      "reason_for_recall": "A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.",
      "recall_initiation_date": "20200203",
      "center_classification_date": "20200401",
      "termination_date": "20201202",
      "report_date": "20200408",
      "code_info": "0454572  0454472  0459726  0449726"
    }
  ]
}