{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "191738",
      "product_res_number": "Z-0669-2022",
      "event_date_initiated": "2021-12-13",
      "event_date_posted": "2022-02-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-09-18",
      "res_event_number": "89495",
      "product_code": "GXQ",
      "k_numbers": [
        "K061487"
      ],
      "product_description": "RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. \nREF: DUMO10125",
      "code_info": "Lot Number 2107292022 Exp. Date: 7/31/2024  \n\nUDI: (01)00813954023267(17)240731(10)2107292022  (note: UDI edited 3/7/2022)",
      "firm_fei_number": "3003300673",
      "recalling_firm": "Collagen Matrix, Inc.",
      "address_1": "110 Commerce Dr",
      "city": "Allendale",
      "state": "NJ",
      "postal_code": "07401-1622",
      "additional_info_contact": "SAME\n201-405-1477",
      "reason_for_recall": "Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On Monday, December 6, 2021, Collagen Matrix Inc began informing the distributors (initial consignees) to place the lot in question on ship hold. \nOn Monday, December 13, 2021, Collagen Matrix began issuing Urgent Medical Device Recall Notice letter to distributors via email.  \nLetter states reason for recall, health risk and action to take:  \n\nCheck your inventory and that of your sub-distributors if applicable to determine if any of the affected product remains in stock and segregate all affected units from your\ninventory for return.  Complete the Certificate of Acknowledgement form with the appropriate information and return within 5 days of receiving this notice.\nThe completed form can be emailed to recalls@collagenmatrix.com or returned by mail to: \nProduct Recall \nCollagen Matrix, Inc. \n15 Thornton Road \nOakland, NJ 07436 \nUpon receipt of the completed form, Collagen Matrix will ship replacement product and a\nprepaid return shipping label will be provided with further instructions for returning product that remains in your possession return the concerned products. If you have any questions after reviewing this notice, please call 201-405-1477, ext. 303 \nbetween 8:00am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail",
      "product_quantity": "10 units",
      "distribution_pattern": "DuraMatrix-Onlay distributed US Nationwide in the states of FL, IN, Puerto Rico, and the countries of Canada, Chile, and Colombia.   \n\nRESODURA matrix onlay distributed in Germany.",
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          "K970851",
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          "K052211",
          "K950956",
          "K131015",
          "K031850",
          "K163456",
          "K973706",
          "K960470",
          "K172603",
          "K061487",
          "K092388",
          "K982282"
        ],
        "registration_number": [
          "1835959",
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        ],
        "fei_number": [
          "1416980",
          "3002719998",
          "3002340648",
          "3045042524",
          "2245304",
          "3025316685",
          "3009039068",
          "1000136478",
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          "3002806315",
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          "3008817245",
          "2648209",
          "3002294946",
          "3003300673",
          "3006017180",
          "3002924436"
        ],
        "device_name": "Dura Substitute",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.5910",
        "device_class": "2"
      }
    }
  ]
}