{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "139886",
      "product_res_number": "Z-0138-2016",
      "event_date_initiated": "2015-08-31",
      "event_date_posted": "2015-10-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-03-02",
      "res_event_number": "72108",
      "product_code": "OOG",
      "k_numbers": [
        "K132640",
        "K133256"
      ],
      "product_description": "ConForMIS iUni Unicondylar Knee Replacement System: \r\n iUNI G2, Left Lateral\r\nCatalog Number: M57220600230 (US)\r\n                                 M5722INT0600230  (OUS)",
      "code_info": "Serial Numbers (US):  0355239 0355108 0355474 0354538 Serial Numbers (OUS):  0353919 0354845 0354849",
      "firm_fei_number": "3009844603",
      "recalling_firm": "ConforMIS, Inc.",
      "address_1": "28 Crosby Dr",
      "city": "Bedford",
      "state": "MA",
      "postal_code": "01730-1402",
      "additional_info_contact": "781-345-9001",
      "reason_for_recall": "May contain small amounts of ethylene glycol residue",
      "root_cause_description": "Process design",
      "action": "ConForMIS issued a Press on August 31, 2015 to the general public The sales force was notified through email. The sales personnel for affected accounts that had upcoming surgeries scheduled were asked to confirm that the affected surgeries were cancelled and that the devices were not used in surgery (Formal notification letters will be distributed to the affected accounts by Tuesday, September 8, 2015. The user required to confirm their understanding of the recall and to return any unused product to ConforMIS. Distribution of the letters conducted in two phases as described below:\r\nPhase 1-Surgeons with product for which the surgery has not yet been completed\r\nPhase 2-Surgeons for whom product was confirmed to have been\r\nconsumed/implanted. An updated Surgeon letter dated September 8, 2015 issued  includes additional information for devices that have been used in surgery.\r\n\r\nContact your local ConforMIS representative or Amita Shah, at 17813459164.",
      "product_quantity": "7 units",
      "distribution_pattern": "Distributed Nationwide and in Germany, Switzerland, and UK.",
      "openfda": {
        "k_number": [
          "K230850",
          "K203421"
        ],
        "registration_number": [
          "1724955",
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        ],
        "fei_number": [
          "1000137563",
          "3006694268",
          "3001084824",
          "3014833750",
          "1219655",
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        ],
        "device_name": "Knee Arthroplasty Implantation System",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3560",
        "device_class": "2"
      }
    }
  ]
}