{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210341",
      "product_res_number": "Z-0262-2025",
      "event_date_initiated": "2024-09-26",
      "event_date_posted": "2024-10-30",
      "recall_status": "Open, Classified",
      "res_event_number": "95466",
      "product_code": "GXQ",
      "k_numbers": [
        "K152481"
      ],
      "product_description": "Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US\nLot CT007694",
      "code_info": "Part# 80-1477US\nLot# CT007694\nUDI# 10886704079477",
      "firm_fei_number": "3003418325",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "1100 Campus Rd",
      "city": "Princeton",
      "state": "NJ",
      "postal_code": "08540-6650",
      "additional_info_contact": "Lacey Gigante\n1-609-212-9004",
      "reason_for_recall": "Out of specification endotoxin levels.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "An URGENT - FIELD SAFETY NOTICE dated 9/26/24 was sent to the customer.\n\nActions to be Taken by Distributors:\n1. If you do have the affected product listed in Table 1, remove the product from further\ndistribution and place them in quarantine.\n2. If you do have affected product, check the box on the enclosed form  I do have affected product. \n3. If you do not have affected product, check the box,  I do not have affected product. \n4. Complete the attached  Distributor Reply Form  in  Appendix 1  and return to\nFCA1@integralife.com or electronic FAX to 1-609-750-4220.\n5. Keep a copy of the form for your records.\n6. Please manage the returns with your customers per your process : credit can be\nprovided if your customers have any product to return and they return it to you.\n7. Forward a copy of the enclosed Field Safety Notice to any of your customers that have\npurchased the affected product. If you need a copy of a  Customer Reply Form , use the\none in  Appendix 2,  as applicable.\n\nPLEASE NOTE THAT REGARDLESS OF WHETHER YOU HAVE THE AFFECTED PRODUCT OR\nNOT   A COMPLETED ACKNOWLEDGEMENT IS REQUIRED\n\nFinally, if required by the national medical device regulation of your distribution area, please ensure this Field Safety Corrective Action is notified to the national competent authorities.\n\nThank you for your cooperation with this Field Safety Corrective Action and for returning the attached Reply Form. See return instructions on top of the reply forms in Appendix 1.\nPlease feel free to contact our Post Market Surveillance Department at FCA1@integralife.com for any additional questions.",
      "product_quantity": "128 units",
      "distribution_pattern": "China",
      "openfda": {
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          "K031850",
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        "registration_number": [
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        "fei_number": [
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        ],
        "device_name": "Dura Substitute",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.5910",
        "device_class": "2"
      }
    }
  ]
}