{
  "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,
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  },
  "results": [
    {
      "cfres_id": "184215",
      "product_res_number": "Z-0492-2021",
      "event_date_initiated": "2020-10-19",
      "event_date_created": "2020-11-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-07-13",
      "res_event_number": "86628",
      "product_code": "NPM",
      "k_numbers": [
        "K120601"
      ],
      "product_description": "Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126",
      "code_info": "Lots: 81901651,82000466",
      "firm_fei_number": "3009439101",
      "recalling_firm": "Geistlich Pharma North America, Inc.",
      "address_1": "202 Carnegie Ctr Ste 103 202 Carnegie Ctr",
      "address_2": "Ste 103",
      "city": "Princeton",
      "state": "NJ",
      "postal_code": "08540-6239",
      "additional_info_contact": "SAME\n202-942-5120",
      "reason_for_recall": "Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane",
      "root_cause_description": "Device Design",
      "action": "Geistlich Pharma North America, Inc. issued \nUrgent Medical Device Notification letter on 10/19/20 stating reason for recall, health risk and action to take:\nAction Requested of Customer\n1. Please complete the Acknowledgement and Receipt Form even if you do not have affected product on hand.\n2. If you still have inventory of Geistlich Bio-Oss Pen with the impacted lot numbers, please immediately discontinue use and return all affected product together with the completed response form. A customer care representative will contact you to coordinate your refund and/or a replacement of goods.\n3. If you have experienced this issue and have not reported this to date, please contact Geistlich Pharma North America, Inc.\n4. If the product has been further distributed to other customers, please forward this notice and report to Geistlich Pharma North America.\nWe apologize for this inconvenience and appreciate your attention to this matter. If you have any questions, please contact us at 855-799-5500 or orders@geistlich-na.com",
      "product_quantity": "537 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the country of Japan.",
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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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