{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 8
    }
  },
  "results": [
    {
      "cfres_id": "221370",
      "product_res_number": "Z-2901-2026",
      "event_date_initiated": "2026-06-15",
      "event_date_posted": "2026-08-06",
      "recall_status": "Open, Classified",
      "res_event_number": "99345",
      "product_code": "SFD",
      "product_description": "Brand Name: COAPTIUM Connect\nProduct Name: COAPTIUM Connect\nModel/Catalog Number: NCOCO1510\nSoftware Version: N/A\nProduct Description: In situ polymerizing peripheral nerve repair device\nComponent: N/A",
      "code_info": "Lot Code: Model No NCOCO1510; UDI-DI 03760279380070; Lot Numbers 250700041 and 251000032",
      "firm_fei_number": "3021453307",
      "recalling_firm": "TISSIUM SA",
      "address_1": "74 Rue Du Faubourg Saint-Antoine",
      "country": "France",
      "additional_info_contact": "Hallie ARLOTTA\n1-317-9957384",
      "reason_for_recall": "Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.",
      "root_cause_description": "Incorrect or no expiration date",
      "action": "On June 25, 2026, the firm began notifying consignees via direct visit by medical representatives to deliver the Customer Recall Notification Letter in person.\n\nRepresentatives removed affected units from customer shelves, collected completed response forms, and provided conforming replacement product on the same day.",
      "distribution_pattern": "US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.",
      "openfda": {
        "k_number": [
          "DEN240066",
          "K251957"
        ],
        "registration_number": [
          "3010383847",
          "3015546200",
          "3010659146",
          "3021453307",
          "3002807295",
          "3010178296"
        ],
        "fei_number": [
          "3010383847",
          "3015546200",
          "3003110073",
          "3010659146",
          "3021453307",
          "3002807295"
        ],
        "device_name": "In Situ Polymerizing Peripheral Nerve Repair Device",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.5270",
        "device_class": "2"
      }
    }
  ]
}