{
  "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",
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  "results": [
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      "cfres_id": "185027",
      "product_res_number": "Z-0810-2021",
      "event_date_initiated": "2020-12-17",
      "event_date_created": "2021-01-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-08-07",
      "res_event_number": "87002",
      "product_code": "LOF",
      "pma_numbers": [
        "P900009"
      ],
      "product_description": "EXOGEN Ultrasound Coupling Gel",
      "code_info": "UDI: M937710344001. Part #71034475, Lot # 190235, 200207; Part # 71034694, Lot # 190235, 190263, 200218, 200228; Part # 71034695, Lot # 190235, 200207; Part # 81079892, Lot # 190204, 190211, 190213, 190226, 190228, 190250, 190251, 190252, 200212, 200215, 200227, 200229, 200240; Part # 81087015, Lot # 190215, 190230, 190235T, 200201, 200203, 200212T, 200215T, 200228T, 200240T",
      "firm_fei_number": "3027669735",
      "recalling_firm": "Bioventus, LLC",
      "address_1": "1900 Charles Bryan Rd Ste 275",
      "city": "Cordova",
      "state": "TN",
      "postal_code": "38016-5285",
      "additional_info_contact": "Thomas Hill\n919-474-6715",
      "reason_for_recall": "Product may contain white particulates that are microbial in nature.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Device Recall Notice 3010203571-12/14/20-001-R was sent to customers beginning 12/17/2020. Customers were instructed to dispose of the product and verify disposal lot and quantity.",
      "product_quantity": "115,584 units",
      "distribution_pattern": "United States (Nationwide), Australia, Austria, Belgium, Canada, Cyprus, Denmark, France, Germany, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom",
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        "device_name": "Stimulator, Bone Growth, Non-Invasive",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "890.5870",
        "device_class": "2"
      }
    }
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}