{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "216511",
      "product_res_number": "Z-0582-2026",
      "event_date_initiated": "2025-10-17",
      "event_date_posted": "2025-11-21",
      "recall_status": "Open, Classified",
      "res_event_number": "97753",
      "product_code": "NQA",
      "pma_numbers": [
        "P930021"
      ],
      "product_description": "Emdogain;\nArticle Numbers: (1) 440.230V10, (2) 475.132V10;",
      "code_info": "1. Article Number: 440.230V10;\nUDI-DI: N/A;\nLot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80;\n\n2. Article Number: 475.132V10;\nUDI-DI: N/A;\nLot Numbers: CRL56, HPHJ1;",
      "firm_fei_number": "1000121052",
      "recalling_firm": "Straumann USA LLC",
      "address_1": "60 Minuteman Rd",
      "city": "Andover",
      "state": "MA",
      "postal_code": "01810-1008",
      "additional_info_contact": "Jennifer M. Jackson, MS, RAC\n978-747-2560",
      "reason_for_recall": "The possibility for this product that is intended for demonstration purposes only to be placed in patients.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On October 17, 2025 Urgent Field Safety Action letters were sent to customers. Action to be taken: 1. 1.\tCheck your inventory for the affected article/lot numbers.  If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically.  Please return the affected items to the attention of Jennifer Jackson at Straumann USA, LLC for credit as indicated on the Customer Confirmation Form. 2. 2.\tIn all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided. Transmission of the Field Safety Notice\nThis notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred.  The Food and Drug Administration (FDA) has been informed about this Field Safety Corrective Action.  We apologize for any inconvenience that this may cause.",
      "product_quantity": "61 units",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.",
      "openfda": {
        "device_name": "Biologic Material, Dental",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.3930",
        "device_class": "3",
        "pma_number": [
          "P040013",
          "P930021"
        ],
        "registration_number": [
          "9613348",
          "3011175224",
          "9612827",
          "2024024",
          "3007884119",
          "3005941719",
          "3008816891"
        ],
        "fei_number": [
          "3011175224",
          "2024024",
          "3002806508",
          "3007884119",
          "3002807111",
          "3004975279",
          "3008816891"
        ]
      }
    }
  ]
}