{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "94911",
      "product_res_number": "Z-0453-2011",
      "event_date_initiated": "2010-09-29",
      "event_date_posted": "2010-11-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-04-23",
      "res_event_number": "56912",
      "product_code": "GXQ",
      "k_numbers": [
        "K072207"
      ],
      "product_description": "DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches.\nNon Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA\nDuraGen XS is indicated as a dural substitute for repair of dura matter.",
      "code_info": "Catalog number DXM1057, Lot number 1073141, 1092075, 1095785, 1101988.",
      "firm_fei_number": "3003418325",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "311 Enterprise Dr",
      "city": "Plainsboro",
      "state": "NJ",
      "postal_code": "08536-3344",
      "additional_info_contact": "Nicole Carmon\n609-936-6947",
      "reason_for_recall": "Test results no longer support a 3 year shelf life.",
      "root_cause_description": "Other",
      "action": "Integra LifeSciences Corporation sent an URGENT Product Recall Notification letter dated September 29, 2010, to all affected customers.  Integra NeruoSpecialists were informed of the recall via telephone conference call and recall notification letters sent by e-mail. Letters were also sent to customers by Federal Express with copies of e-mail provided to Interga Neuro Specialists on October 1, 2010.\nThe letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to immediately quarantine any affected product and contact Integra Customer Service at 1-800-654-2873, select option 5, followed by option 3.\nCustomers were instructed to fill out and return the enclosed \"Recall Acknowledgement and Return Form\" indicating whether or not they possessed any of the affected product.\nFor any questions related to this recall call 1-800-654-2873 and selection option 1.",
      "product_quantity": "112",
      "distribution_pattern": "Nationwide Distribution including AK, AL, AZ, CA, CO, DC, DE, FL, GA, HI, IL, IN, LA, MA, MD, ME, MN, MO, MT, NC, ND, NH, NJ, NM, NY, OK, PA, TN, TX, UT, VA, VT, WA, WI, AND WV.",
      "openfda": {
        "k_number": [
          "K250420",
          "K131015",
          "K183513",
          "K132850",
          "K161278",
          "K970851",
          "K163456",
          "K982101",
          "K141608",
          "K172603",
          "K153613",
          "K223445",
          "K982180",
          "K072207",
          "K092388",
          "K950956",
          "K960470",
          "K251191",
          "K061208",
          "K063117",
          "K122791",
          "K032693",
          "K982282",
          "K991413",
          "K041518",
          "K120600",
          "K040888",
          "K041000",
          "K212943",
          "K043427",
          "K953969",
          "K161370",
          "K152481",
          "K980548",
          "K031850",
          "K113071",
          "K973706",
          "K052211",
          "K150825",
          "K061487",
          "K984534",
          "K021477",
          "K131792"
        ],
        "registration_number": [
          "2245304",
          "3012429393",
          "1225991",
          "1121308",
          "3002719998",
          "3012421607",
          "1220948",
          "3045042524",
          "2249852",
          "1416980",
          "1835959",
          "3003418325",
          "3025316685",
          "3035387162",
          "9681465",
          "9610612",
          "1319660",
          "2648988",
          "2183620",
          "3012448339",
          "3012479318",
          "3009417901",
          "3004464325",
          "1319639",
          "3003300673",
          "3020659113",
          "3002294946",
          "3034676720",
          "2916714",
          "9680260",
          "2650143",
          "3004681519",
          "3002924436",
          "3027448274",
          "3008812560",
          "3030126381",
          "3006017180",
          "1000393132",
          "3004170064",
          "3007284313",
          "3000270450",
          "3009039068"
        ],
        "fei_number": [
          "2245304",
          "1000138054",
          "3012429393",
          "3002315844",
          "1121308",
          "3002719998",
          "3012421607",
          "1220948",
          "3045042524",
          "1416980",
          "3000204775",
          "3008817245",
          "3003418325",
          "3025316685",
          "3035387162",
          "2648209",
          "2183620",
          "3012448339",
          "3012479318",
          "3009417901",
          "3004464325",
          "3003300673",
          "3020659113",
          "3002807113",
          "3002294946",
          "3002806315",
          "3034676720",
          "2916714",
          "3002516348",
          "3003870583",
          "3002924436",
          "3027448274",
          "3008812560",
          "3030126381",
          "3006017180",
          "1000393132",
          "3002340648",
          "1000136478",
          "3004170064",
          "3007284313",
          "3000270450",
          "3009039068"
        ],
        "device_name": "Dura Substitute",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.5910",
        "device_class": "2"
      }
    }
  ]
}