{
  "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": "2026-08-13",
    "results": {
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      "product_res_number": "Z-0314-2026",
      "event_date_initiated": "2025-08-26",
      "event_date_posted": "2025-11-05",
      "recall_status": "Open, Classified",
      "res_event_number": "97869",
      "product_code": "OAS",
      "k_numbers": [
        "K212303"
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      "product_description": "Osstem Dental X-Ray System T2. Product Model Numbers\nT2-C and T2-CS.",
      "code_info": "UDI Codes:\n08800000995601 and 08800000995618.",
      "firm_fei_number": "3003394081",
      "recalling_firm": "OSSTEM Implant Co., Ltd.",
      "address_1": "66-16 Bansong-Ro 513beon-Gil 66-16 busan city haeundae district korea the republic of bansong-ro 513beon-gil",
      "reason_for_recall": "Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted:\n Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.",
      "root_cause_description": "Radiation Control for Health and Safety Act",
      "action": "Osstem Implant issued notification to customers, titled \"URGENT: MEDICAL DEVICE CORRECTION\", dated 08/26/2025, provided reason for recall, product description with UDI codes, corrective action, product disposition and contact information.",
      "distribution_pattern": "U.S.",
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}