{
  "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": {
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  "results": [
    {
      "cfres_id": "192298",
      "product_res_number": "Z-0823-2022",
      "event_date_initiated": "2022-02-02",
      "event_date_created": "2022-03-24",
      "recall_status": "Open, Classified",
      "res_event_number": "89721",
      "product_code": "NPM",
      "k_numbers": [
        "K043034"
      ],
      "product_description": "NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects.\nCatalog Number:  5099250",
      "code_info": "Lot Number: BMBU21A1 \nExp. Date: 2024-03-31\nUDI: 00614950007264",
      "firm_fei_number": "1287163",
      "recalling_firm": "Ace Surgical Supply Co., Inc.",
      "address_1": "1034 Pearl St",
      "city": "Brockton",
      "state": "MA",
      "postal_code": "02301-5411",
      "additional_info_contact": "SAME\n800-441-3100",
      "reason_for_recall": "NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair",
      "root_cause_description": "Under Investigation by firm",
      "action": "Ace Surgical issued Urgent Voluntary Recall letter dated 2/4/22 to  US customers via certified mail and customers outside of US contacted via email. Letter states reason for recall, health risk and action to take:\nPlease refer to the lot number on the outer box label. The lot in question is BMBU21A 1.\nIf you confirm this lot number on ACE Surgical Supply product, DO NOT USE THE PRODUCT and segregate it to prevent future use.\nPlease be advised that the recalled lot identified was from a specific batch produced in October 2021. If you have received this notification, our shipping records confirm that you received this specific batch that was affected. \n\nAll products subject to this RECALL will need to be returned to ACE Surgical.\nPlease complete the RESPONSE form and follow the instructions for submission.\n\nIf you do have product to be returned, please return the response form to doreenprice@acesurgical.com.\nIf you do have inventory to return, once the response form is received and confirmed, an ARS Label will be issued. If you have any further questions, please contact Doreen Price 508-588-3100, Extension 781 or doreen price@acesurgical .com.",
      "product_quantity": "31 eaches",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.",
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        "device_name": "Bone Grafting Material, Animal Source",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.3930",
        "device_class": "2",
        "pma_number": [
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