{
  "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": "176515",
      "product_res_number": "Z-0168-2020",
      "event_date_initiated": "2019-09-10",
      "event_date_created": "2019-10-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-05-01",
      "res_event_number": "83855",
      "product_code": "LRN",
      "product_description": "Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.",
      "code_info": "Catalog Number: 321-52-06, All Serial Numbers",
      "firm_fei_number": "1038671",
      "recalling_firm": "Exactech, Inc.",
      "address_1": "2320 NW 66th Ct",
      "city": "Gainesville",
      "state": "FL",
      "postal_code": "32653-1630",
      "additional_info_contact": "Priscilla Bennet Jones\n352-377-1140",
      "reason_for_recall": "Potential for the wire to fracture at the threads and remain in the glenoid.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Exactech notified customers of the recall on about 09/10/2019, via \"URGENT MEDICAL DEVICE RECALL\" letter.  Customers were informed that Exactech had received reports of the 3.2mm K-Wire fracturing at the threads and remaining in the glenoid.  \n\nInstructions included to immediately cease distribution of or use of the product, provide the recall information to accounts that may have the affected product in their possession, identify and quarantine any affected products in inventory, and complete and return the attached Recall Acknowledgement Form and Recall Inventory Response form to Exactech via email at recalls@exac.com.",
      "product_quantity": "158 devices",
      "distribution_pattern": "US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.",
      "openfda": {
        "k_number": [
          "K971682",
          "K900926",
          "K002755",
          "K952783",
          "K892651",
          "K864375",
          "K990355",
          "K942603"
        ],
        "registration_number": [
          "3008556682",
          "1219655",
          "3001278222",
          "3004748528",
          "1526534",
          "2647346",
          "2032098",
          "1720929",
          "9610726",
          "2080222",
          "9616680",
          "3018094310",
          "3010173425",
          "3010362364",
          "1818910",
          "8010379",
          "3025141",
          "2028632",
          "3003120897",
          "3014725904",
          "1043653",
          "9616671",
          "3015440604",
          "3008812251",
          "8031020",
          "8010177",
          "1030489",
          "8043792",
          "3006356043",
          "3013014058",
          "8031010",
          "3006128100",
          "3004464325",
          "3015516266",
          "3006017180",
          "8044172",
          "1824199",
          "2029275",
          "2249697",
          "3008102042",
          "3006001176"
        ],
        "fei_number": [
          "3008556682",
          "1219655",
          "1000125930",
          "3001278222",
          "3004748528",
          "1526534",
          "2647346",
          "1000199976",
          "3002807036",
          "3002821504",
          "3003070421",
          "1720929",
          "2080222",
          "3002854251",
          "3018094310",
          "3010362364",
          "1818910",
          "3002807830",
          "3003120897",
          "3002808269",
          "1000477302",
          "3014725904",
          "3002807172",
          "1043653",
          "3002459190",
          "1000185904",
          "3015440604",
          "3002808293",
          "3002806653",
          "3006356043",
          "3013014058",
          "3006128100",
          "3004464325",
          "3015516266",
          "3006017180",
          "1000125025",
          "1824199",
          "1000306431",
          "3003058448",
          "3006001176",
          "3002924544"
        ],
        "device_name": "Wire, Surgical",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3030",
        "device_class": "2"
      }
    }
  ]
}