{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "177052",
      "product_res_number": "Z-0361-2020",
      "event_date_initiated": "2019-10-02",
      "event_date_created": "2019-11-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-05-19",
      "res_event_number": "84040",
      "product_code": "NDL",
      "product_description": "2.4mm x 2.5  Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.",
      "code_info": "Catalog Number: 351-90-22; UDI Number: 10885862567529;  Expiration Date: 08/28/2028;  Serial Numbers (6189213, 6189221, 6189222, 6189223,  6189228,  6189229, 6189249,  6189262, 6189273);  Packaging Lots Numbers (49079322, 49079321);  Manufacturing Lot Number:19030412",
      "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": "352-377-1140",
      "reason_for_recall": "Potential for the 2.4mm x 2.5  Fluted Pin Pouch to contain a single pin rather than four (4) as intended.",
      "root_cause_description": "Error in labeling",
      "action": "Exactech notified customers on about 10/02/2019, via \"URGENT MEDICAL DEVICE RECALL\" letter.  Customers were informed that the 2.4mm x 2.5\" Fluted Pin Pouch was found to contain a single pin rather than four (4) as labeled.  \n\nInstructions included to immediately cease distribution or use of the affected product, provide the information to customers if further distributed, identify and quarantine any of the affected devices in inventory, and complete and return the provided Recall Acknowledgement Form and Recall Inventory Response Form to Exactech via email to recalls@exac.com.",
      "product_quantity": "9 units",
      "distribution_pattern": "US Nationwide distribution in the states of GA, NY, OH, VA.",
      "openfda": {
        "k_number": [
          "K010847",
          "K010545"
        ],
        "registration_number": [
          "3013564228",
          "3018080016",
          "3014527928",
          "2031009",
          "3016655171",
          "1834331",
          "1526534",
          "3016759112",
          "3007125392",
          "3030183061",
          "1423662"
        ],
        "fei_number": [
          "3013564228",
          "3018080016",
          "3014527928",
          "3016655171",
          "1526534",
          "3016759112",
          "3007125392",
          "3030183061",
          "1000306340",
          "3001236812",
          "3000215273"
        ],
        "device_name": "Pin, Fixation, Smooth, Metallic",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3040",
        "device_class": "2"
      }
    }
  ]
}