{
  "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": "124400",
      "product_res_number": "Z-0481-2014",
      "event_date_initiated": "2013-11-19",
      "event_date_posted": "2013-12-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-10-06",
      "res_event_number": "66978",
      "product_code": "NJM",
      "product_description": "Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets\r\n\r\nAvex CX2 ceramic brackets are intended for use in orthodontic treatment.",
      "code_info": "R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624",
      "firm_fei_number": "1718912",
      "recalling_firm": "Ultradent Products, Inc.",
      "address_1": "505 W 10200 S",
      "city": "South Jordan",
      "state": "UT",
      "postal_code": "84095-3935",
      "additional_info_contact": "Corey Jaseph\n801-553-4420",
      "reason_for_recall": "Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.",
      "root_cause_description": "Process control",
      "action": "Ultradent Products notified consignees via email on November 19, 2013.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to return all unused product.  Sales representatives will pick up remaining unplaced brackets or returns will be sent back using pre-paid envelopes back to Ultradent recall coordinator for quarantine. Consignees were asked to complete evaluation forms to be returned by fax to 800-793-5206.\r\nFor questions regarding this recall call 801-553-4420.",
      "product_quantity": "217 units",
      "distribution_pattern": "Nationwide Distribution including UT, CA, WA, VA, OH, and TN.",
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        "device_name": "Bracket, Ceramic, Orthodontic",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.5470",
        "device_class": "2",
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