{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221721",
      "product_res_number": "Z-3178-2026",
      "event_date_initiated": "2026-07-27",
      "event_date_posted": "2026-09-16",
      "recall_status": "Open, Classified",
      "res_event_number": "99512",
      "product_code": "OYK",
      "k_numbers": [
        "K223326"
      ],
      "product_description": "Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006",
      "code_info": "System Serial Numbers: 18169, 18059.\nREF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.",
      "firm_fei_number": "3014833750",
      "recalling_firm": "restor3d Inc.",
      "address_1": "4001 E Nc 54 Hwy",
      "address_2": "Suite 3160",
      "city": "Durham",
      "state": "NC",
      "postal_code": "27709",
      "additional_info_contact": "Brianna Gabbard\n786-521-0501",
      "reason_for_recall": "Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.",
      "root_cause_description": "Labeling Change Control",
      "action": "On 7/28/2026, recall notices were emailed to customers who were asked to do the following:\n\n1) Segregate and return affected devices.\n2) Complete and return the response form.\n\nIf additional questions, contact firm at 984-201-2310",
      "product_quantity": "2",
      "distribution_pattern": "US Nationwide distribution in the states of FL, CO.",
      "openfda": {
        "device_name": "Ankle Arthroplasty Implantation System",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3110",
        "device_class": "2",
        "k_number": [
          "K241326",
          "K223326",
          "K231585",
          "K193432",
          "K241148",
          "K243173",
          "K243174"
        ],
        "registration_number": [
          "3010470577",
          "3025603301",
          "3008650117",
          "1424434",
          "1724955",
          "3012275107",
          "1057425",
          "3010667733",
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          "3014833750"
        ],
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      }
    }
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}