{
  "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": "203390",
      "product_res_number": "Z-0070-2024",
      "event_date_initiated": "2023-09-11",
      "event_date_posted": "2023-10-06",
      "recall_status": "Open, Classified",
      "res_event_number": "93077",
      "product_code": "OJJ",
      "product_description": "GS0008 2Y - Burn Pack - STL, Item Number 880082025",
      "code_info": "UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16",
      "firm_fei_number": "3014527682",
      "recalling_firm": "ROi CPS LLC",
      "address_1": "3000 E Sawyer Rd",
      "city": "Republic",
      "state": "MO",
      "postal_code": "65738-2758",
      "reason_for_recall": "Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.",
      "root_cause_description": "Other",
      "action": "ROi CPS, LLC issued a Medical Device Correction notice to its sole consignee on 09/11/2023 by email.  The notice explained the issue with the Zimmer Dermatone Blade contained in the kit, the risk, and requested the consignee affix a sticker to the exterior of the kit requesting that the blade be removed and discarded at the time of use.",
      "product_quantity": "103 kits",
      "distribution_pattern": "Missouri",
      "openfda": {
        "registration_number": [
          "1036781",
          "3045816907",
          "1423395",
          "1055236",
          "3007329020",
          "3005012805",
          "3009888344",
          "3045857302",
          "1047429",
          "2320762",
          "1054241",
          "3004111573",
          "1423537",
          "1417592",
          "1643817",
          "3010700223",
          "3045816902",
          "3015495690",
          "1928237",
          "1030451",
          "3015173212",
          "1061124",
          "3004122598",
          "2029015",
          "3008374791",
          "3005034064",
          "9616088",
          "1043214",
          "3008808560",
          "3010452421",
          "3035642068"
        ],
        "fei_number": [
          "3045816907",
          "3007329020",
          "3005012805",
          "3009888344",
          "3045857302",
          "1047429",
          "3004111573",
          "1417592",
          "1643817",
          "3003040625",
          "3010700223",
          "3000717925",
          "3004601847",
          "3045816902",
          "3015495690",
          "1928237",
          "1030451",
          "3015173212",
          "3004122598",
          "1000160458",
          "1000512168",
          "3001236905",
          "3008374791",
          "3005034064",
          "1043214",
          "1000112877",
          "1000111918",
          "3002902735",
          "1000112968",
          "3010452421",
          "3035642068"
        ],
        "device_name": "Burn Kit Without Drug",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4022",
        "device_class": "1"
      }
    }
  ]
}