{
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2457-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "IMPIX TLIF, REF numbers:    a) B15130607S,   b) B15130609S,   c) B15130611S,   d) B15130613S,   e) B15130615S,   f) B15900806,   g) B15900906,   h) B15901006,   i) B15901106,   j) B15901206,   k) B15901306; intervertebral fusion device - lumbar",
  "description": "FDA recall Z-2457-2023 — Medicrea International is recalling IMPIX TLIF, REF numbers:    a) B15130607S,   b) B15130609S,   c) B15130611S,   d) B15130613S,   e) B15130615S,   f) B15900806,   g) B15900906,   h) B15901006,   i) B15901106,   j) B15901206,   k) B15901306; intervertebral fusion device - lumbar (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2457-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "IMPIX TLIF, REF numbers:    a) B15130607S,   b) B15130609S,   c) B15130611S,   d) B15130613S,   e) B15130615S,   f) B15900806,   g) B15900906,   h) B15901006,   i) B15901106,   j) B15901206,   k) B15901306; intervertebral fusion device - lumbar",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medicrea International"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2457-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2457-2023: Medicrea International is recalling IMPIX TLIF, REF numbers:    a) B15130607S,   b) B15130609S,   c) B15130611S,   d) B15130613S,   e) B15130615S,   f) B15900806,   g) B15900906,   h) B15901006,   i) B15901106,   j) B15901206,   k) B15901306; intervertebral fusion device - lumbar",
      "text": "The FDA logged enforcement record Z-2457-2023: Medicrea International is voluntarily recalling IMPIX TLIF, REF numbers:    a) B15130607S,   b) B15130609S,   c) B15130611S,   d) B15130613S,   e) B15130615S,   f) B15900806,   g) B15900906,   h) B15901006,   i) B15901106,   j) B15901206,   k) B15901306; intervertebral fusion device - lumbar — 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) B15130607S, GTIN 03613720245681, Lot Numbers:  19B0894, 19C0092, 19G0921, 19G0922, 19L0045, 20B0320, 20B0477, 20B0478, 20B0479;  b) B15130609S, GTIN 03613720245674, Lot Numbers:  18D1077, 19J0690, 20A0042, 20A0423, 20A1000, 20B0322, 20B0476, 20F0908, 20H0481, 20I0099, 20J0734;  c) B15130611S, GTIN 03613720193760, Lot Numbers:  19B0895, 19D0071, 19E0170, 19I0695, 19J0324, 20A0228, 20B0731, 20B0732;  d) B15130613S, GTIN 03613720193784, Lot Numbers:  18G0602, 18I0594, 19C0091, 19F0641, 19L0032, 20F0909;  e) B15130615S, GTIN 03613720193807, Lot Numbers:  20I0097;  f) B15900806, GTIN 03613720275572, Lot Numbers:  19A0329R;  g) B15900906, GTIN 03613720275589, Lot Numbers:  19A0340R;  h) B15901006, GTIN 03613720275596, Lot Numbers:  19A0339R;  i) B15901106, GTIN 03613720275602, Lot Numbers:  19A0338R, 19G0337;  j) B15901206, GTIN 03613720275619, Lot Numbers:  19A0337R;  k) B15901306, GTIN 03613720275626, Lot Numbers:  19A0336R. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-2457-2023&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-2457-2023&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-2457-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2457-2023 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": {
        "groundingType": "AdjudicativeAct",
        "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-2457-2023&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-2457-2023&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-2457-2023/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": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2457-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2457-2023",
            "Status": "recorded"
          }
        },
        {
          "@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"
          }
        },
        {
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          "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) B15130607S, GTIN 03613720245681, Lot Numbers:  19B0894, 19C0092, 19G0921, 19G0922, 19L0045, 20B0320, 20B0477, 20B0478, 20B0479;  b) B15130609S, GTIN 03613720245674, Lot Numbers:  18D1077, 19J0690, 20A0042, 20A0423, 20A1000, 20B0322, 20B0476, 20F0908, 20H0481, 20I0099, 20J0734;  c) B15130611S, GTIN 03613720193760, Lot Numbers:  19B0895, 19D0071, 19E0170, 19I0695, 19J0324, 20A0228, 20B0731, 20B0732;  d) B15130613S, GTIN 03613720193784, Lot Numbers:  18G0602, 18I0594, 19C0091, 19F0641, 19L0032, 20F0909;  e) B15130615S, GTIN 03613720193807, Lot Numbers:  20I0097;  f) B15900806, GTIN 03613720275572, Lot Numbers:  19A0329R;  g) B15900906, GTIN 03613720275589, Lot Numbers:  19A0340R;  h) B15901006, GTIN 03613720275596, Lot Numbers:  19A0339R;  i) B15901106, GTIN 03613720275602, Lot Numbers:  19A0338R, 19G0337;  j) B15901206, GTIN 03613720275619, Lot Numbers:  19A0337R;  k) B15901306, GTIN 03613720275626, Lot Numbers:  19A0336R",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US nationwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}