{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "112490",
      "product_res_number": "Z-0122-2013",
      "event_date_initiated": "2012-02-04",
      "event_date_posted": "2012-10-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-12-12",
      "res_event_number": "63081",
      "product_code": "ONN",
      "product_description": "\"****ORTHO SENSOR**12-123-A  Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***\"\nRx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***.\n\nIs the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.",
      "code_info": "Version 1.82",
      "firm_fei_number": "3008592715",
      "recalling_firm": "Orthosensor",
      "address_1": "1560 Sawgrass Corporate Pkwy",
      "address_2": "4th Floor",
      "city": "Sunrise",
      "state": "FL",
      "postal_code": "33323-2858",
      "additional_info_contact": "Juan C. Fernandez\n813-6452855",
      "reason_for_recall": "Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was updated to version 1.82, validated on 02/13/12). Recall was initiated due to customer feedback which included the line of site between the knee ba lancer and the Link station was obstructed by OR metal stands or trays or the knee balancer device was placed atop of or near the metal stands or trays, interru",
      "root_cause_description": "Software design",
      "action": "Orthosensor did not provide a written customer notification. As the recall was reported to the FDA well after all nine of the products were corrected (the recall stemmed from an initial inspection of the firm), then no customer notification was requested.  \n\nThe removal and replacement of the previous version of the Graphic User Interface Software is being handled internally by members of Operations and the Sales force. The items the firm is recalling is software, and the software cannot be returned; the old version (version 1.8) would be erased. The new version 1.82 would be installed and downloaded into the equipment at the site during servicing. \n\nThis does not involve the customer of which none are consignees. Effectiveness checks associated with the update of the software is being handled internally by the Operations and the Sales force.\n\nFurther questions please call  (813) 645-2855.",
      "product_quantity": "9",
      "distribution_pattern": "Nationwide Distribution including the states of CA, FL, MI and NY.",
      "openfda": {
        "k_number": [
          "K200587",
          "K150372",
          "K132104",
          "K220830",
          "K090474",
          "K162237",
          "K131767",
          "K252524",
          "K241298",
          "K242616",
          "K180459",
          "K130380",
          "K193580",
          "K253507",
          "K093046",
          "K200665",
          "K262253",
          "K070108"
        ],
        "registration_number": [
          "3015516266",
          "3007521480",
          "9617840",
          "3004530184",
          "3004180226",
          "3033434191",
          "3013756293",
          "3005180920",
          "3008110533",
          "1721676"
        ],
        "fei_number": [
          "3015516266",
          "3001598088",
          "3007521480",
          "3004530184",
          "3033434191",
          "3013756293",
          "3005180920",
          "3008110533",
          "1721676",
          "3003714383"
        ],
        "device_name": "Intraoperative Orthopedic Joint Assessment Aid",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4560",
        "device_class": "2"
      }
    }
  ]
}