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  "name": "Brand Name: FIREBIRD\" SI Fusion System  Product Name: FIREBIRD\" SI Fusion System  Model/Catalog Number: 18-1025SP\t11mm X 25mm FIREBIRD SI Screw;  18-1030SP\t11mm X 30mm FIREBIRD SI Screw;  18-1035SP\t11mm X 35mm FIREBIRD SI Screw;  18-1040SP\t11mm X 40mm FIREBIRD SI Screw;  18-1045SP\t11mm X 45mm FIREBIRD SI Screw;  18-1050SP\t11mm X 50mm FIREBIRD SI Screw;  18-1055SP\t11mm X 55mm FIREBIRD SI Screw;  18-1060SP\t11mm X 60mm FIREBIRD SI Screw;  18-1065SP\t11mm X 65mm FIREBIRD SI Screw;  18-1070SP\t11mm X 70mm FIREBIRD SI Screw;  18-2025SP\t12mm X 25mm FIREBIRD SI Screw;  18-2030SP\t12mm X 30mm FIREBIRD SI Screw;  18-2035SP\t12mm X 35mm FIREBIRD SI Screw;  18-2040SP\t12mm X 40mm FIREBIRD SI Screw;  18-2045SP\t12mm X 45mm FIREBIRD SI Screw;  18-2050SP\t12mm X 50mm FIREBIRD SI Screw;  18-2055SP\t12mm X 55mm FIREBIRD SI Screw;  18-2060SP\t12mm X 60mm FIREBIRD SI Screw;  18-2065SP\t12mm X 65mm FIREBIRD SI Screw;  18-2070SP\t12mm X 70mm FIREBIRD SI Screw",
  "description": "FDA recall Z-0894-2026 — Orthofix U.S. LLC is recalling Brand Name: FIREBIRD\" SI Fusion System  Product Name: FIREBIRD\" SI Fusion System  Model/Catalog Number: 18-1025SP\t11mm X 25mm FIREBIRD SI Screw;  18-1030SP\t11mm X 30mm FIREBIRD SI Screw;  18-1035SP\t11mm X 35mm FIREBIRD SI Screw;  18-1040SP\t11mm X 40mm FIREBIRD SI Screw;  18-1045SP\t11mm X 45mm FIREBIRD SI Screw;  18-1050SP\t11mm X 50mm FIREBIRD SI Screw;  18-1055SP\t11mm X 55mm FIREBIRD SI Screw;  18-1060SP\t11mm X 60mm FIREBIRD SI Screw;  18-1065SP\t11mm X 65mm FIREBIRD SI Screw;  18-1070SP\t11mm X 70mm FIREBIRD SI Screw;  18-2025SP\t12mm X 25mm FIREBIRD SI Screw;  18-2030SP\t12mm X 30mm FIREBIRD SI Screw;  18-2035SP\t12mm X 35mm FIREBIRD SI Screw;  18-2040SP\t12mm X 40mm FIREBIRD SI Screw;  18-2045SP\t12mm X 45mm FIREBIRD SI Screw;  18-2050SP\t12mm X 50mm FIREBIRD SI Screw;  18-2055SP\t12mm X 55mm FIREBIRD SI Screw;  18-2060SP\t12mm X 60mm FIREBIRD SI Screw;  18-2065SP\t12mm X 65mm FIREBIRD SI Screw;  18-2070SP\t12mm X 70mm FIREBIRD SI Screw (Devices, Class III). 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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    "@type": "schema:MedicalDevice",
    "name": "Brand Name: FIREBIRD\" SI Fusion System  Product Name: FIREBIRD\" SI Fusion System  Model/Catalog Number: 18-1025SP\t11mm X 25mm FIREBIRD SI Screw;  18-1030SP\t11mm X 30mm FIREBIRD SI Screw;  18-1035SP\t11mm X 35mm FIREBIRD SI Screw;  18-1040SP\t11mm X 40mm FIREBIRD SI Screw;  18-1045SP\t11mm X 45mm FIREBIRD SI Screw;  18-1050SP\t11mm X 50mm FIREBIRD SI Screw;  18-1055SP\t11mm X 55mm FIREBIRD SI Screw;  18-1060SP\t11mm X 60mm FIREBIRD SI Screw;  18-1065SP\t11mm X 65mm FIREBIRD SI Screw;  18-1070SP\t11mm X 70mm FIREBIRD SI Screw;  18-2025SP\t12mm X 25mm FIREBIRD SI Screw;  18-2030SP\t12mm X 30mm FIREBIRD SI Screw;  18-2035SP\t12mm X 35mm FIREBIRD SI Screw;  18-2040SP\t12mm X 40mm FIREBIRD SI Screw;  18-2045SP\t12mm X 45mm FIREBIRD SI Screw;  18-2050SP\t12mm X 50mm FIREBIRD SI Screw;  18-2055SP\t12mm X 55mm FIREBIRD SI Screw;  18-2060SP\t12mm X 60mm FIREBIRD SI Screw;  18-2065SP\t12mm X 65mm FIREBIRD SI Screw;  18-2070SP\t12mm X 70mm FIREBIRD SI Screw",
    "manufacturer": {
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      "name": "Orthofix U.S. LLC"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0894-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0894-2026: Orthofix U.S. LLC is recalling Brand Name: FIREBIRD\" SI Fusion System  Product Name: FIREBIRD\" SI Fusion System  Model/Catalog Number: 18-1025SP\t11mm X 25mm FIREBIRD SI Screw;  18-1030SP\t11mm X 30mm FIREBIRD SI Screw;  18-1035SP\t11mm X 35mm FIREBIRD SI Screw;  18-1040SP\t11mm X 40mm FIREBIRD SI Screw;  18-1045SP\t11mm X 45mm FIREBIRD SI Screw;  18-1050SP\t11mm X 50mm FIREBIRD SI Screw;  18-1055SP\t11mm X 55mm FIREBIRD SI Screw;  18-1060SP\t11mm X 60mm FIREBIRD SI Screw;  18-1065SP\t11mm X 65mm FIREBIRD SI Screw;  18-1070SP\t11mm X 70mm FIREBIRD SI Screw;  18-2025SP\t12mm X 25mm FIREBIRD SI Screw;  18-2030SP\t12mm X 30mm FIREBIRD SI Screw;  18-2035SP\t12mm X 35mm FIREBIRD SI Screw;  18-2040SP\t12mm X 40mm FIREBIRD SI Screw;  18-2045SP\t12mm X 45mm FIREBIRD SI Screw;  18-2050SP\t12mm X 50mm FIREBIRD SI Screw;  18-2055SP\t12mm X 55mm FIREBIRD SI Screw;  18-2060SP\t12mm X 60mm FIREBIRD SI Screw;  18-2065SP\t12mm X 65mm FIREBIRD SI Screw;  18-2070SP\t12mm X 70mm FIREBIRD SI Screw",
      "text": "The FDA logged enforcement record Z-0894-2026: Orthofix U.S. LLC is voluntarily recalling Brand Name: FIREBIRD\" SI Fusion System  Product Name: FIREBIRD\" SI Fusion System  Model/Catalog Number: 18-1025SP\t11mm X 25mm FIREBIRD SI Screw;  18-1030SP\t11mm X 30mm FIREBIRD SI Screw;  18-1035SP\t11mm X 35mm FIREBIRD SI Screw;  18-1040SP\t11mm X 40mm FIREBIRD SI Screw;  18-1045SP\t11mm X 45mm FIREBIRD SI Screw;  18-1050SP\t11mm X 50mm FIREBIRD SI Screw;  18-1055SP\t11mm X 55mm FIREBIRD SI Screw;  18-1060SP\t11mm X 60mm FIREBIRD SI Screw;  18-1065SP\t11mm X 65mm FIREBIRD SI Screw;  18-1070SP\t11mm X 70mm FIREBIRD SI Screw;  18-2025SP\t12mm X 25mm FIREBIRD SI Screw;  18-2030SP\t12mm X 30mm FIREBIRD SI Screw;  18-2035SP\t12mm X 35mm FIREBIRD SI Screw;  18-2040SP\t12mm X 40mm FIREBIRD SI Screw;  18-2045SP\t12mm X 45mm FIREBIRD SI Screw;  18-2050SP\t12mm X 50mm FIREBIRD SI Screw;  18-2055SP\t12mm X 55mm FIREBIRD SI Screw;  18-2060SP\t12mm X 60mm FIREBIRD SI Screw;  18-2065SP\t12mm X 65mm FIREBIRD SI Screw;  18-2070SP\t12mm X 70mm FIREBIRD SI Screw — reason: Labeling contains claims that are not consistently  present.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-11-03. Affected lots/codes: Lot Code: All Lots/ UDI: 18-1025SP 18257200140084; 18-1030SP 18257200140091; 18-1035SP 18257200140107; 18-1040SP 18257200140114; 18-1045SP 18257200140275; 18-1050SP 18257200140121; 18-1055SP 18257200140138; 18-1060SP 18257200140145; 18-1065SP 18257200140152; 18-1070SP 18257200140169; 18-2025SP 18257200140176; 18-2030SP 18257200140183; 18-2035SP 18257200140190; 18-2040SP 18257200140206; 18-2045SP 18257200140213; 18-2050SP 18257200140220; 18-2055SP 18257200140237; 18-2060SP 18257200140244; 18-2065SP 18257200140251; 18-2070SP 18257200140268. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0894-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0894-2026&lang=eng"
        }
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0894-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0894-2026 as Class III",
      "text": "The FDA assigned this recall Class III: Class III — the FDA judged the product is unlikely to cause 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class III",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0894-2026&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0894-2026/boundary",
      "@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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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-0894-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0894-2026",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class III",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
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        {
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Orthofix U.S. LLC",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Labeling contains claims that are not consistently  present.",
            "Status": "recorded"
          }
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-11-03",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Lot Code: All Lots/ UDI: 18-1025SP 18257200140084; 18-1030SP 18257200140091; 18-1035SP 18257200140107; 18-1040SP 18257200140114; 18-1045SP 18257200140275; 18-1050SP 18257200140121; 18-1055SP 18257200140138; 18-1060SP 18257200140145; 18-1065SP 18257200140152; 18-1070SP 18257200140169; 18-2025SP 18257200140176; 18-2030SP 18257200140183; 18-2035SP 18257200140190; 18-2040SP 18257200140206; 18-2045SP 18257200140213; 18-2050SP 18257200140220; 18-2055SP 18257200140237; 18-2060SP 18257200140244; 18-2065SP 18257200140251; 18-2070SP 18257200140268",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.",
            "Status": "recorded"
          }
        }
      ]
    }
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}