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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1118-2025.jsonld",
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  "name": "UNiD\" Adaptive Spine Intelligence    UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929    Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer.    The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning).  The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.",
  "description": "FDA recall Z-1118-2025 — Medicrea International is recalling UNiD\" Adaptive Spine Intelligence    UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929    Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer.    The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning).  The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "UNiD\" Adaptive Spine Intelligence    UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929    Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer.    The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning).  The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medicrea International"
    }
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  "claims": [
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1118-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1118-2025: Medicrea International is recalling UNiD\" Adaptive Spine Intelligence    UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929    Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer.    The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning).  The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.",
      "text": "The FDA logged enforcement record Z-1118-2025: Medicrea International is voluntarily recalling UNiD\" Adaptive Spine Intelligence    UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929    Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer.    The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning).  The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. — reason: Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system.  Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-03. Affected lots/codes: UNiD HUB is not a medical device and thus does not have a CFN or GTIN code.  UNiD Spine Analyzer Product Number SW3002 UDI-DI code: 03613720286929 No lot numbers. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1118-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-1118-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
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      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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      "name": "FDA recall details — Z-1118-2025",
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            "Value": "Z-1118-2025",
            "Status": "recorded"
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          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medicrea International",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system.  Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2024-12-03",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "UNiD HUB is not a medical device and thus does not have a CFN or GTIN code.  UNiD Spine Analyzer Product Number SW3002 UDI-DI code: 03613720286929 No lot numbers",
            "Status": "recorded"
          }
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.  O.U.S.: Argentina Australia Belgium Brazil Bulgaria Chile Czech Republic Denmark Finland France Germany Greece Iceland Ireland Israel Italy Luxembourg Malaysia Mexico Monaco Morocco Netherlands New Zealand Poland Portugal Singapore South Korea Spain Sweden Switzerland United Kingdom",
            "Status": "recorded"
          }
        }
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