{
  "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": "166714",
      "product_res_number": "Z-0083-2019",
      "event_date_initiated": "2018-07-12",
      "event_date_created": "2018-10-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-06-27",
      "res_event_number": "80845",
      "product_code": "ONN",
      "k_numbers": [
        "K180459"
      ],
      "product_description": "OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.",
      "code_info": "Lot numbers 20569, 20576, 20594, and 20618, UDI 00816818021447.",
      "firm_fei_number": "3008592715",
      "recalling_firm": "Orthosensor, Inc.",
      "address_1": "1855 Griffin Rd Ste A310 1855 Griffin Rd",
      "address_2": "Ste A310",
      "city": "Dania",
      "state": "FL",
      "postal_code": "33004-2401",
      "additional_info_contact": "Mr. Jack Leo\n954-577-7770",
      "reason_for_recall": "Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Letters dated 7/12/2018 were either delivered by the sales representatives or issued via email to their consignees on 7/13/2018 explaining the reason for recall and requesting return of the devices, if still available, for replacement. The firm expanded the recall via letter dated 8/29/2018 for delivery by sales representatives or via sales representative email on 8/30/2018.",
      "product_quantity": "37 devices",
      "distribution_pattern": "Distribution was made CA, FL, IL, IN, MI, NY, and NC.   Foreign distribution was made to Australia.  There was no government/military distribution.",
      "openfda": {
        "k_number": [
          "K253507",
          "K150372",
          "K252524",
          "K132104",
          "K180459",
          "K070108",
          "K193580",
          "K262253",
          "K200587",
          "K162237",
          "K090474",
          "K131767",
          "K242616",
          "K200665",
          "K220830",
          "K241298",
          "K093046",
          "K130380"
        ],
        "registration_number": [
          "3004180226",
          "3008110533",
          "3004530184",
          "3005180920",
          "3013756293",
          "9617840",
          "3033434191",
          "3007521480",
          "3015516266",
          "1721676"
        ],
        "fei_number": [
          "3008110533",
          "3004530184",
          "3005180920",
          "3013756293",
          "3003714383",
          "3033434191",
          "3007521480",
          "3001598088",
          "3015516266",
          "1721676"
        ],
        "device_name": "Intraoperative Orthopedic Joint Assessment Aid",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4560",
        "device_class": "2"
      }
    }
  ]
}