{
  "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": "2026-09-05",
    "results": {
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      "cfres_id": "221182",
      "product_res_number": "Z-2699-2026",
      "event_date_initiated": "2026-06-08",
      "event_date_posted": "2026-07-08",
      "recall_status": "Open, Classified",
      "res_event_number": "99277",
      "product_code": "QJJ",
      "product_description": "KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,",
      "code_info": "UDI/DI 10850061082029, Lot Numbers:  1779407586392-0, 1779138889952-0, 1778173992342-0",
      "firm_fei_number": "3030265369",
      "recalling_firm": "Klowen Braces",
      "address_1": "1900 Firman Dr Ste 800 1900 Firman Dr",
      "address_2": "Ste 800",
      "city": "Richardson",
      "state": "TX",
      "postal_code": "75081-6769",
      "additional_info_contact": "Nichole Leahy-Glass\n737-265-5220",
      "reason_for_recall": "A product error defect may cause incorrect bracket placement.",
      "root_cause_description": "Process control",
      "action": "KLOwen Orthodontics initially notified their consignees of the recall via telephone on 6/8/2026 and followed with a letter send certified mail on 6/16/2026.  The notice explained the issue, potential risk which would arise from the use of the affected product and requested the following:  \n\"REQUIRED ACTIONS FOR YOUR PRACTICE\n1\tAssess the impact.   Please review your inventory immediately to identify the affected KLOwen IDB trays and execute the following steps for unused trays.\n2\tDiscard the affected tray to KLOwen.   Do not proceed with bonding with the affected tray. Remove the tray from the case box and discard the tray into the trash.\n3\tConfirm disposal.   Please sign this document confirming disposal of the tray.\n4\tReceive replacement tray.   A correct replacement tray is in production and will be shipped to your practice as soon as it is completed. Your field representative will confirm the estimated ship date.\"  \nThe KLOwen field representative is the primary point of contact throughout this process and will keep customers informed of replacement timing and any additional actions needed.",
      "product_quantity": "3 units",
      "distribution_pattern": "US Nationwide distribution in the states of OH, TX, SC VA.",
      "openfda": {
        "device_name": "Indirect Bonding Tray",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.5410",
        "device_class": "1",
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