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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2459-2023.jsonld",
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  "name": "GRANVIA-C, REF numbers:    a)¿¿¿¿¿ A13111427,   b)¿¿¿¿ A13112567,   c)¿¿¿¿¿ A13113456,   d)¿¿¿¿ A13131516,   e)¿¿¿¿ A13131789,   f)¿¿¿¿¿¿ A13132012,   g)¿¿¿¿¿ B13111014,   h)¿¿¿¿ B13111015,   i)¿¿¿¿¿¿ B13111016,   j)¿¿¿¿¿¿ B13111017,   k)¿¿¿¿¿ B13111025,   l)¿¿¿¿¿¿ B13111026,   m)¿¿¿ B13111027,   n)¿¿¿¿ B13111034,   o)¿¿¿¿ B13111035,   p)¿¿¿¿ B13111036; intervertebral fusion device - cervical",
  "description": "FDA recall Z-2459-2023 — Medicrea International is recalling GRANVIA-C, REF numbers:    a)¿¿¿¿¿ A13111427,   b)¿¿¿¿ A13112567,   c)¿¿¿¿¿ A13113456,   d)¿¿¿¿ A13131516,   e)¿¿¿¿ A13131789,   f)¿¿¿¿¿¿ A13132012,   g)¿¿¿¿¿ B13111014,   h)¿¿¿¿ B13111015,   i)¿¿¿¿¿¿ B13111016,   j)¿¿¿¿¿¿ B13111017,   k)¿¿¿¿¿ B13111025,   l)¿¿¿¿¿¿ B13111026,   m)¿¿¿ B13111027,   n)¿¿¿¿ B13111034,   o)¿¿¿¿ B13111035,   p)¿¿¿¿ B13111036; intervertebral fusion device - cervical (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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
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      "name": "U.S. Food & Drug Administration"
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "GRANVIA-C, REF numbers:    a)¿¿¿¿¿ A13111427,   b)¿¿¿¿ A13112567,   c)¿¿¿¿¿ A13113456,   d)¿¿¿¿ A13131516,   e)¿¿¿¿ A13131789,   f)¿¿¿¿¿¿ A13132012,   g)¿¿¿¿¿ B13111014,   h)¿¿¿¿ B13111015,   i)¿¿¿¿¿¿ B13111016,   j)¿¿¿¿¿¿ B13111017,   k)¿¿¿¿¿ B13111025,   l)¿¿¿¿¿¿ B13111026,   m)¿¿¿ B13111027,   n)¿¿¿¿ B13111034,   o)¿¿¿¿ B13111035,   p)¿¿¿¿ B13111036; intervertebral fusion device - cervical",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medicrea International"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2459-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2459-2023: Medicrea International is recalling GRANVIA-C, REF numbers:    a)¿¿¿¿¿ A13111427,   b)¿¿¿¿ A13112567,   c)¿¿¿¿¿ A13113456,   d)¿¿¿¿ A13131516,   e)¿¿¿¿ A13131789,   f)¿¿¿¿¿¿ A13132012,   g)¿¿¿¿¿ B13111014,   h)¿¿¿¿ B13111015,   i)¿¿¿¿¿¿ B13111016,   j)¿¿¿¿¿¿ B13111017,   k)¿¿¿¿¿ B13111025,   l)¿¿¿¿¿¿ B13111026,   m)¿¿¿ B13111027,   n)¿¿¿¿ B13111034,   o)¿¿¿¿ B13111035,   p)¿¿¿¿ B13111036; intervertebral fusion device - cervical",
      "text": "The FDA logged enforcement record Z-2459-2023: Medicrea International is voluntarily recalling GRANVIA-C, REF numbers:    a)¿¿¿¿¿ A13111427,   b)¿¿¿¿ A13112567,   c)¿¿¿¿¿ A13113456,   d)¿¿¿¿ A13131516,   e)¿¿¿¿ A13131789,   f)¿¿¿¿¿¿ A13132012,   g)¿¿¿¿¿ B13111014,   h)¿¿¿¿ B13111015,   i)¿¿¿¿¿¿ B13111016,   j)¿¿¿¿¿¿ B13111017,   k)¿¿¿¿¿ B13111025,   l)¿¿¿¿¿¿ B13111026,   m)¿¿¿ B13111027,   n)¿¿¿¿ B13111034,   o)¿¿¿¿ B13111035,   p)¿¿¿¿ B13111036; intervertebral fusion device - cervical — reason: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-07-12. Affected lots/codes: a)¿¿¿¿¿ A13111427, GTIN 03613720235637, Lot Numbers:  19D0379, 19J0745, 20F0921;  b)¿¿¿¿ A13112567, GTIN 03613720235651, Lot Numbers:  18F0191, 19D0380;  c)¿¿¿¿¿ A13113456, GTIN 03613720235668. Lot Numbers:  19C0241, 20F0929;  d)¿¿¿¿ A13131516, GTIN 03613720235682, Lot Numbers:  21A0438;  e)¿¿¿¿ A13131789, GTIN 03613720235699, Lot Numbers:  21D0856;  f)¿¿¿¿¿¿ A13132012, GTIN 03613720235705, Lot Numbers:  21D0857;  g)¿¿¿¿¿ B13111014, GTIN 03613720192602, Lot Numbers:  18J0704, 19I0437, 19L0317, 20B0743, 20H0170, 20I0346;  h)¿¿¿¿ B13111015, GTIN 03613720192619, Lot Numbers:  18A0891, 18L0331, 19B0305, 19D0744, 19G0689, 19I0840, 19K0222, 20A0967, 20B0167, 20I0201, 20J0513, 21A0098,;  i)¿¿¿¿¿¿ B13111016, GTIN 03613720192626, Lot Numbers:  18J0705, 19C0759, 19I0435, 19L0103, 20G0353, 20K0398, 21A0099, 21A0574, 21F0151;  j)¿¿¿¿¿¿ B13111017, GTIN 03613720192633, Lot Numbers:  18J0706, 21D0097, 21I0125;  k)¿¿¿¿¿ B13111025, GTIN 03613720192664, Lot Numbers:  18D0593, 19A0658, 19C0394, 19K0343, 20J0514;  l)¿¿¿¿¿¿ B13111026, GTIN 03613720192671, Lot Numbers:  18J0707, 20J0516, 21I0072;  m)¿¿¿ B13111027, GTIN 03613720192688, Lot Numbers:  18J0709, 21A0575, 21I0126;  n)¿¿¿¿ B13111034, GTIN 03613720192718, Lot Numbers:  18B1066, 18D0594, 18E0614, 18H0671, 18K0878, 18L0389, 19A0354, 19A0377, 19D0306, 19D0307, 19D0578, 19E0387, 19J0465, 19K0068, 19L0607, 20B0744, 20G0354, 20K0399, 21A0203, 21A0732, 21F0153;  o)¿¿¿¿ B13111035, GTIN 03613720192725, Lot Numbers:  18A0892, 18J0465, 18J0710, 19A0355, 19B0304, 19B0394, 19B0395, 19D0579, 19F0100R, 19J0466, 19K0069, 19L0394, 20B0745, 20C0296, 20G0355, 20I0348, 20K0434, 21A0103;  p)¿¿¿¿ B13111036, GTIN 03613720192732, Lot Numbers:  18B1067, 18F1031, 18J0466, 18J0711, 18L0390, 19A0356, 19B0915, 19D0581, 19G0690, 19K0157, 19L0804, 20E0256, 20I0349, 20J0512, 21A0104. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "SourceCitation",
        "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-2459-2023&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-2459-2023&lang=eng"
        }
      },
      "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-2459-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2459-2023 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2459-2023&lang=eng",
        "value": "Class II",
        "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-2459-2023&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-2459-2023/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."
    }
  ],
  "hasPart": [
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      "name": "FDA recall details — Z-2459-2023",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2459-2023",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medicrea International",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-07-12",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a)¿¿¿¿¿ A13111427, GTIN 03613720235637, Lot Numbers:  19D0379, 19J0745, 20F0921;  b)¿¿¿¿ A13112567, GTIN 03613720235651, Lot Numbers:  18F0191, 19D0380;  c)¿¿¿¿¿ A13113456, GTIN 03613720235668. Lot Numbers:  19C0241, 20F0929;  d)¿¿¿¿ A13131516, GTIN 03613720235682, Lot Numbers:  21A0438;  e)¿¿¿¿ A13131789, GTIN 03613720235699, Lot Numbers:  21D0856;  f)¿¿¿¿¿¿ A13132012, GTIN 03613720235705, Lot Numbers:  21D0857;  g)¿¿¿¿¿ B13111014, GTIN 03613720192602, Lot Numbers:  18J0704, 19I0437, 19L0317, 20B0743, 20H0170, 20I0346;  h)¿¿¿¿ B13111015, GTIN 03613720192619, Lot Numbers:  18A0891, 18L0331, 19B0305, 19D0744, 19G0689, 19I0840, 19K0222, 20A0967, 20B0167, 20I0201, 20J0513, 21A0098,;  i)¿¿¿¿¿¿ B13111016, GTIN 03613720192626, Lot Numbers:  18J0705, 19C0759, 19I0435, 19L0103, 20G0353, 20K0398, 21A0099, 21A0574, 21F0151;  j)¿¿¿¿¿¿ B13111017, GTIN 03613720192633, Lot Numbers:  18J0706, 21D0097, 21I0125;  k)¿¿¿¿¿ B13111025, GTIN 03613720192664, Lot Numbers:  18D0593, 19A0658, 19C0394, 19K0343, 20J0514;  l)¿¿¿¿¿¿ B13111026, GTIN 03613720192671, Lot Numbers:  18J0707, 20J0516, 21I0072;  m)¿¿¿ B13111027, GTIN 03613720192688, Lot Numbers:  18J0709, 21A0575, 21I0126;  n)¿¿¿¿ B13111034, GTIN 03613720192718, Lot Numbers:  18B1066, 18D0594, 18E0614, 18H0671, 18K0878, 18L0389, 19A0354, 19A0377, 19D0306, 19D0307, 19D0578, 19E0387, 19J0465, 19K0068, 19L0607, 20B0744, 20G0354, 20K0399, 21A0203, 21A0732, 21F0153;  o)¿¿¿¿ B13111035, GTIN 03613720192725, Lot Numbers:  18A0892, 18J0465, 18J0710, 19A0355, 19B0304, 19B0394, 19B0395, 19D0579, 19F0100R, 19J0466, 19K0069, 19L0394, 20B0745, 20C0296, 20G0355, 20I0348, 20K0434, 21A0103;  p)¿¿¿¿ B13111036, GTIN 03613720192732, Lot Numbers:  18B1067, 18F1031, 18J0466, 18J0711, 18L0390, 19A0356, 19B0915, 19D0581, 19G0690, 19K0157, 19L0804, 20E0256, 20I0349, 20J0512, 21A0104",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US nationwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}