{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "198119",
      "product_res_number": "Z-1171-2023",
      "event_date_initiated": "2023-01-13",
      "event_date_posted": "2023-02-24",
      "recall_status": "Open, Classified",
      "res_event_number": "91527",
      "product_code": "LFB",
      "product_description": "Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.",
      "code_info": "Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340",
      "firm_fei_number": "3008719017",
      "recalling_firm": "Summit Medical, LLC",
      "address_1": "815 Vikings Pkwy Ste 100 815 Vikings Pkwy",
      "address_2": "Ste 100",
      "city": "Eagan",
      "state": "MN",
      "postal_code": "55121-1139",
      "additional_info_contact": "Jeff Esselman\n651-789-3921",
      "reason_for_recall": "Sterile product pouches were not sealed.",
      "root_cause_description": "Process control",
      "action": "The firm issued \"URGENT RECALL NOTICE\" Letters dated 1/13/2023 via email.  The letter explained the issue and requested the consignee remove the product from inventory and inspect the pouch to verify it is sealed.  If the pouch is not sealed, the consignee is to cut the product with scissors and dispose of it.  Results of their inspection are to be reported to the recalling firm by email using the enclosed form.  A number is listed to arrange for replacement product.  The consignee is to indicate on the form that they have read and understand the recall instructions, have checked their stock and disposed of inventory affected, and that they have none of the product left in inventory.\n\nIf you have any questions, contact Director of Quality Assurance at 651-789-3939 or email: jesselman@innoviamedical.com.",
      "product_quantity": "30 devices",
      "distribution_pattern": "US Distribution was made to CO, FL, GA, LA, MA, and ME.   There was no government/military distribution.\n\nOUS Foreign distribution was made to Canada.",
      "openfda": {
        "device_name": "Button, Nasal Septal",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U",
        "k_number": [
          "K131745",
          "K822637",
          "K972060",
          "K901366",
          "K871200",
          "K781529",
          "K920994",
          "K862497",
          "K982667",
          "K871072",
          "K850492",
          "K013696"
        ],
        "registration_number": [
          "3008719017",
          "3017636737",
          "2025182",
          "2183762",
          "1926681",
          "3018094310",
          "9612501",
          "2183744",
          "1045254",
          "1219795",
          "1052728",
          "1220850"
        ],
        "fei_number": [
          "3008719017",
          "3017636737",
          "2025182",
          "2183762",
          "3003495548",
          "1926681",
          "3018094310",
          "1000113735",
          "2183744",
          "1045254",
          "1219795",
          "1220850"
        ]
      }
    }
  ]
}