{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "cfres_id": "215723",
      "product_res_number": "Z-2576-2025",
      "event_date_initiated": "2025-08-21",
      "event_date_posted": "2025-09-17",
      "recall_status": "Open, Classified",
      "res_event_number": "97480",
      "product_code": "GCZ",
      "product_description": "Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile",
      "code_info": "All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548001",
      "firm_fei_number": "3006803588",
      "recalling_firm": "Folsom Metal Products, Inc.",
      "address_1": "1449 Court Pl",
      "city": "Pelham",
      "state": "AL",
      "postal_code": "35124-1858",
      "additional_info_contact": "Ms. Jennifer Martin\n205-733-0901",
      "reason_for_recall": "Labeling includes shelf life that has not been validated.",
      "root_cause_description": "Incorrect or no expiration date",
      "action": "On August 21, 2025, Frortier Devices issued a \"Urgent: Medical Device Recall\" Notification to affected consignees via FedEx. On August 22, 2025, Frontier reissued the notification to correct an incorrect product number. Frontier asked consignees to take the following actions:\n\n1. Immediately examine your inventory and quarantine any affected units.\n2.If you have affected units: Return product to Frontier Devices at the address listed, OR Destroy product on-site and complete the enclosed Certificate of Destruction Form.\n3. If you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please share this notice with all users within your organization. If the product has been transferred to a different facility, please make them aware of the notice.\n4. Complete and return the enclosed Medical Device Recall Response Acknowledgment Form as soon as possible, even if no affected product remains in your possession. Please have them complete the acknowledgement response form and return it to you.",
      "product_quantity": "3790 unit",
      "distribution_pattern": "US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.",
      "openfda": {
        "k_number": [
          "K904536",
          "K870809",
          "K893870",
          "K801610",
          "K802806"
        ],
        "registration_number": [
          "3015183635",
          "1836161",
          "2918699",
          "3013046958",
          "3012447612",
          "3014683120",
          "3010097171",
          "8022032",
          "3013496867",
          "1820334",
          "3007597038",
          "8040278",
          "1058584",
          "1065595",
          "3004215117",
          "2028175",
          "8030607",
          "3017609565",
          "9613079",
          "1054811",
          "3022320321",
          "2133928",
          "3002761766",
          "3038718579",
          "3016050940",
          "3021987422",
          "1000179416",
          "3008254127",
          "3009165919",
          "1526439",
          "2434839",
          "3043648115",
          "3025414363",
          "1923569",
          "3009998573",
          "3008747271",
          "3023657851",
          "9613926",
          "3010304565",
          "3017910185",
          "3012783431",
          "3005440795",
          "2030624",
          "3003807268",
          "2029275",
          "3013552516",
          "2424366",
          "2183449",
          "3009513193",
          "2134285"
        ],
        "fei_number": [
          "3015183635",
          "3006509795",
          "3002287318",
          "1000125440",
          "3013046958",
          "3012447612",
          "3014683120",
          "3010097171",
          "3013496867",
          "1820334",
          "3000206435",
          "3004215117",
          "3002468384",
          "3006803588",
          "1000347621",
          "3017609565",
          "3022320321",
          "3002761766",
          "3038718579",
          "3016050940",
          "3021987422",
          "3008254127",
          "3009165919",
          "1526439",
          "1000306431",
          "3002807214",
          "2434839",
          "3043648115",
          "3025414363",
          "1000219637",
          "3000717902",
          "1923569",
          "3009998573",
          "3008747271",
          "3002750084",
          "3023657851",
          "3004216008",
          "1000402972",
          "3010304565",
          "3017910185",
          "3012783431",
          "3005440795",
          "3001717360",
          "3000718212",
          "3003807268",
          "3013552516",
          "1000114185",
          "2424366",
          "2183449",
          "3009513193"
        ],
        "device_name": "Retainer, Surgical",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4800",
        "device_class": "1"
      }
    }
  ]
}