{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216120",
      "product_res_number": "Z-0145-2026",
      "event_date_initiated": "2025-09-19",
      "event_date_posted": "2025-10-14",
      "recall_status": "Open, Classified",
      "res_event_number": "97618",
      "product_code": "SBF",
      "k_numbers": [
        "K243950"
      ],
      "product_description": "Brand Name: ARVIS\nProduct Name: ARVIS\" Shoulder\nModel/Catalog Number: IN-27300, Arvis Surgical Planning Software\nSoftware Version: V2025.1.2\nProduct Description: Intended Use: The ARVIS\" system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components.  \n\nDescription: ARVIS Shoulder is a computer-controlled surgical navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient s preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments. \n\nThe device s workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient s CT reconstructed digital bone model and bony landmarks. The shoulder navigation application software then matches the patient s digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.",
      "code_info": "Software Version V2025.1.2",
      "firm_fei_number": "3013552417",
      "recalling_firm": "Kico Knee Innovation Company",
      "address_1": "Suite 3, Building 1, 20 Bridge St 20 suite 3 building 1 bridge st",
      "city": "Pymble",
      "country": "Australia",
      "reason_for_recall": "Complaint identified  issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.",
      "root_cause_description": "Software change control",
      "action": "On September 12, 2025, Kico Knee Innovation Company issued a recall notice to affected consignees. Kico asked consignees to take the following actions: \n\n1. No actions are required by the surgeon users.\n\n2. For the plans affected, Kico has quarantined these as they are not suitable for clinical use.\n\n3. A long-term solution has been implemented to return the system to the specification of the most recently cleared device. We will contact surgeon users to login and re-plan their cases for upcoming surgeries.",
      "product_quantity": "21 systems",
      "distribution_pattern": "US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL.",
      "openfda": {
        "k_number": [
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          "K261854",
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          "K233899",
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          "K202750",
          "K251639",
          "K220905",
          "K252170",
          "K230789",
          "K253805",
          "K243975",
          "K232280",
          "K193559",
          "K220104",
          "K242271",
          "K231284",
          "K243950",
          "K243980",
          "K250255",
          "K211254",
          "K241525",
          "K231611",
          "K210859",
          "K251737",
          "K230567",
          "K250108",
          "K190929",
          "K243623",
          "K202152",
          "K213034",
          "K241481",
          "K220554",
          "K241870",
          "K213751",
          "K211188",
          "K252054",
          "K220733",
          "K223769",
          "K242569",
          "K252530"
        ],
        "registration_number": [
          "3008869747",
          "3020703212",
          "8043933",
          "3016571711",
          "1526534",
          "1226544",
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          "3005180920",
          "3025287527",
          "3015151147"
        ],
        "fei_number": [
          "3008869747",
          "3002808269",
          "3003128516",
          "3020703212",
          "3016571711",
          "1526534",
          "3003714383",
          "3016438694",
          "3002619595",
          "3010163695",
          "3004142400",
          "3010197287",
          "3016566146",
          "3009973505",
          "3010047454",
          "3008110533",
          "3036756245",
          "3007441485",
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          "3006946276",
          "3019878658",
          "3016676864",
          "3010031846",
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          "3002806577",
          "3003058448",
          "3006017180",
          "3033509898",
          "3005180920",
          "3025287527",
          "3015151147"
        ],
        "device_name": "Orthopedic Augmented Reality",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4560",
        "device_class": "2"
      }
    }
  ]
}