{
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    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
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    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
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    "claimType": "au:claimType",
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    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2452-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "IMPIX 3D, REF numbers:     a)\tB242C09122810,   b)\tB242C10062810,   c)\tB242C10122810,   d)\tB242C11062810,   e)\tB242C11122810,   f)\tB242C12062810,   g)\tB242C12122810,   h)\tB242C12123310,   i)\tB242C13062810,   j)\tB242C13122810,   k)\tB242C14122810,   l)\tB242C15122810,   m)\tB247C07062410,   n)\tB247C07062810,   o)\tB247C07063210,   p)\tB247C08062410,   q)\tB247C08062810,   r)\tB247C08063210,   s)\tB247C09062410,   t)\tB247C09062810,   u)\tB247C09063210,   v)\tB247C10062410,   w)\tB247C10062810,   x)\tB247C10063210,   y)\tB247C11062410,   z)\tB247C11062810,   aa)\tB247C11063210,   bb)\tB247C12062410,   cc)\tB247C12062810,   dd)\tB247C12063210,   ee)\tB247C13062410,   ff)\tB247C13062810,   gg)\tB247C13063210,   hh)\tB247C14062410,   ii)\tB247C14062810,   jj)\tB247C14063210,   kk)\tB247C15062810,   ll)\tB247C15063210;  intervertebral fusion device - lumbar",
  "description": "FDA recall Z-2452-2023 — Medicrea International is recalling IMPIX 3D, REF numbers:     a)\tB242C09122810,   b)\tB242C10062810,   c)\tB242C10122810,   d)\tB242C11062810,   e)\tB242C11122810,   f)\tB242C12062810,   g)\tB242C12122810,   h)\tB242C12123310,   i)\tB242C13062810,   j)\tB242C13122810,   k)\tB242C14122810,   l)\tB242C15122810,   m)\tB247C07062410,   n)\tB247C07062810,   o)\tB247C07063210,   p)\tB247C08062410,   q)\tB247C08062810,   r)\tB247C08063210,   s)\tB247C09062410,   t)\tB247C09062810,   u)\tB247C09063210,   v)\tB247C10062410,   w)\tB247C10062810,   x)\tB247C10063210,   y)\tB247C11062410,   z)\tB247C11062810,   aa)\tB247C11063210,   bb)\tB247C12062410,   cc)\tB247C12062810,   dd)\tB247C12063210,   ee)\tB247C13062410,   ff)\tB247C13062810,   gg)\tB247C13063210,   hh)\tB247C14062410,   ii)\tB247C14062810,   jj)\tB247C14063210,   kk)\tB247C15062810,   ll)\tB247C15063210;  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/",
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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/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2452-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "IMPIX 3D, REF numbers:     a)\tB242C09122810,   b)\tB242C10062810,   c)\tB242C10122810,   d)\tB242C11062810,   e)\tB242C11122810,   f)\tB242C12062810,   g)\tB242C12122810,   h)\tB242C12123310,   i)\tB242C13062810,   j)\tB242C13122810,   k)\tB242C14122810,   l)\tB242C15122810,   m)\tB247C07062410,   n)\tB247C07062810,   o)\tB247C07063210,   p)\tB247C08062410,   q)\tB247C08062810,   r)\tB247C08063210,   s)\tB247C09062410,   t)\tB247C09062810,   u)\tB247C09063210,   v)\tB247C10062410,   w)\tB247C10062810,   x)\tB247C10063210,   y)\tB247C11062410,   z)\tB247C11062810,   aa)\tB247C11063210,   bb)\tB247C12062410,   cc)\tB247C12062810,   dd)\tB247C12063210,   ee)\tB247C13062410,   ff)\tB247C13062810,   gg)\tB247C13063210,   hh)\tB247C14062410,   ii)\tB247C14062810,   jj)\tB247C14063210,   kk)\tB247C15062810,   ll)\tB247C15063210;  intervertebral fusion device - lumbar",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medicrea International"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2452-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2452-2023: Medicrea International is recalling IMPIX 3D, REF numbers:     a)\tB242C09122810,   b)\tB242C10062810,   c)\tB242C10122810,   d)\tB242C11062810,   e)\tB242C11122810,   f)\tB242C12062810,   g)\tB242C12122810,   h)\tB242C12123310,   i)\tB242C13062810,   j)\tB242C13122810,   k)\tB242C14122810,   l)\tB242C15122810,   m)\tB247C07062410,   n)\tB247C07062810,   o)\tB247C07063210,   p)\tB247C08062410,   q)\tB247C08062810,   r)\tB247C08063210,   s)\tB247C09062410,   t)\tB247C09062810,   u)\tB247C09063210,   v)\tB247C10062410,   w)\tB247C10062810,   x)\tB247C10063210,   y)\tB247C11062410,   z)\tB247C11062810,   aa)\tB247C11063210,   bb)\tB247C12062410,   cc)\tB247C12062810,   dd)\tB247C12063210,   ee)\tB247C13062410,   ff)\tB247C13062810,   gg)\tB247C13063210,   hh)\tB247C14062410,   ii)\tB247C14062810,   jj)\tB247C14063210,   kk)\tB247C15062810,   ll)\tB247C15063210;  intervertebral fusion device - lumbar",
      "text": "The FDA logged enforcement record Z-2452-2023: Medicrea International is voluntarily recalling IMPIX 3D, REF numbers:     a)\tB242C09122810,   b)\tB242C10062810,   c)\tB242C10122810,   d)\tB242C11062810,   e)\tB242C11122810,   f)\tB242C12062810,   g)\tB242C12122810,   h)\tB242C12123310,   i)\tB242C13062810,   j)\tB242C13122810,   k)\tB242C14122810,   l)\tB242C15122810,   m)\tB247C07062410,   n)\tB247C07062810,   o)\tB247C07063210,   p)\tB247C08062410,   q)\tB247C08062810,   r)\tB247C08063210,   s)\tB247C09062410,   t)\tB247C09062810,   u)\tB247C09063210,   v)\tB247C10062410,   w)\tB247C10062810,   x)\tB247C10063210,   y)\tB247C11062410,   z)\tB247C11062810,   aa)\tB247C11063210,   bb)\tB247C12062410,   cc)\tB247C12062810,   dd)\tB247C12063210,   ee)\tB247C13062410,   ff)\tB247C13062810,   gg)\tB247C13063210,   hh)\tB247C14062410,   ii)\tB247C14062810,   jj)\tB247C14063210,   kk)\tB247C15062810,   ll)\tB247C15063210;  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) B242C09122810, GTIN 03613720284444, Lot Numbers:  20B0926, 20B0984;  b) B242C10062810, GTIN 03613720270522, Lot Numbers:  18E0499;  c) B242C10122810, GTIN 03613720284451, Lot Numbers: 20B0928, 20B0985;  d) B242C11062810, GTIN 03613720270539, Lot Numbers:  18D0708, 19F0261;  e) B242C11122810, GTIN 03613720284468, Lot Numbers:  20B0930, 20B0986;  f) B242C12062810, GTIN 03613720270546, Lot Numbers:  18D0709, 19G0038;  g) B242C12122810, GTIN 03613720284475, Lot Numbers:  20B0931, 20B0987;  h) B242C12123310, GTIN 03613720284543, Lot Numbers:  20C0374;  i) B242C13062810, GTIN 03613720270553, Lot Numbers:  18D0710, 19F0263;  j) B242C13122810, GTIN 03613720284482, Lot Numbers:  20E0343;  k) B242C14122810, GTIN 03613720284499, Lot Numbers:  20B0932;  l) B242C15122810, GTIN 03613720284505, Lot Numbers:  20B0933;  m) B247C07062410, GTIN 03613720272762, Lot Numbers:  18D0965, 18I0576, 18L0085;  n) B247C07062810, GTIN 03613720272779, Lot Numbers:  18I0577, 18L0084;  o) B247C07063210, GTIN 03613720272786, Lot Numbers:  18I0492;  p) B247C08062410, GTIN 03613720272533, Lot Numbers:  18D0966, 18I0579, 18L0086;  q) B247C08062810, GTIN 03613720272526, Lot Numbers:  18I0554, 18I0580;  r) B247C08063210, GTIN 03613720272540, Lot Numbers:  18I0493;  s) B247C09062410, GTIN 03613720272557, Lot Numbers:  18D0967, 18I0582, 18L0088, 19F0264;  t) B247C09062810, GTIN 03613720272564, Lot Numbers:  18H0611R, 18H0611R/1, 18I0555;  u) B247C09063210, GTIN 03613720272571, Lot Numbers:  18I0494;  v) B247C10062410, GTIN 03613720272588, Lot Numbers:  18D0968, 18I0584, 18L0089, 20A0451;  w) B247C10062810, GTIN 03613720272595, Lot Numbers:  18H0612, 18H0612/1, 18H0612/2;  x) B247C10063210, GTIN 03613720272601, Lot Numbers:  18I0495;  y) B247C11062410, GTIN 03613720272618, Lot Numbers:  18D0969, 18I0586, 19F0265;  z) B247C11062810, GTIN 03613720272625, Lot Numbers:  18H0613, 18H0613/1;  aa) B247C11063210, GTIN 03613720272632, Lot Numbers:  18I0496;  bb) B247C12062410, GTIN 03613720272649, Lot Numbers:  18D0970;  cc) B247C12062810, GTIN 03613720272656, Lot Numbers:  18H0614, 18I0558;  dd) B247C12063210, GTIN 03613720272663, Lot Numbers:  18I0560;  ee) B247C13062410, GTIN 03613720272670, Lot Numbers:  18I0589;  ff) B247C13062810, GTIN 03613720272687, Lot Numbers:  18H0615;  gg) B247C13063210, GTIN 03613720272694, Lot Numbers:  18I0561;  hh) B247C14062410, GTIN 03613720272700, Lot Numbers:  18L0099;  ii) B247C14062810, GTIN 03613720272717, Lot Numbers:  18H0616/1/1, 18H0616/2;  jj) B247C14063210, GTIN 03613720272724, Lot Numbers:  18I0562;  kk) B247C15062810, GTIN 03613720272748, Lot Numbers:  18I0498;  ll) B247C15063210, GTIN 03613720272755, Lot Numbers:  18I0563. 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-2452-2023&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-2452-2023&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-2452-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2452-2023 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-2452-2023&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-2452-2023&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-2452-2023/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-2452-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2452-2023",
            "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"
          }
        },
        {
          "@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"
          }
        },
        {
          "@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) B242C09122810, GTIN 03613720284444, Lot Numbers:  20B0926, 20B0984;  b) B242C10062810, GTIN 03613720270522, Lot Numbers:  18E0499;  c) B242C10122810, GTIN 03613720284451, Lot Numbers: 20B0928, 20B0985;  d) B242C11062810, GTIN 03613720270539, Lot Numbers:  18D0708, 19F0261;  e) B242C11122810, GTIN 03613720284468, Lot Numbers:  20B0930, 20B0986;  f) B242C12062810, GTIN 03613720270546, Lot Numbers:  18D0709, 19G0038;  g) B242C12122810, GTIN 03613720284475, Lot Numbers:  20B0931, 20B0987;  h) B242C12123310, GTIN 03613720284543, Lot Numbers:  20C0374;  i) B242C13062810, GTIN 03613720270553, Lot Numbers:  18D0710, 19F0263;  j) B242C13122810, GTIN 03613720284482, Lot Numbers:  20E0343;  k) B242C14122810, GTIN 03613720284499, Lot Numbers:  20B0932;  l) B242C15122810, GTIN 03613720284505, Lot Numbers:  20B0933;  m) B247C07062410, GTIN 03613720272762, Lot Numbers:  18D0965, 18I0576, 18L0085;  n) B247C07062810, GTIN 03613720272779, Lot Numbers:  18I0577, 18L0084;  o) B247C07063210, GTIN 03613720272786, Lot Numbers:  18I0492;  p) B247C08062410, GTIN 03613720272533, Lot Numbers:  18D0966, 18I0579, 18L0086;  q) B247C08062810, GTIN 03613720272526, Lot Numbers:  18I0554, 18I0580;  r) B247C08063210, GTIN 03613720272540, Lot Numbers:  18I0493;  s) B247C09062410, GTIN 03613720272557, Lot Numbers:  18D0967, 18I0582, 18L0088, 19F0264;  t) B247C09062810, GTIN 03613720272564, Lot Numbers:  18H0611R, 18H0611R/1, 18I0555;  u) B247C09063210, GTIN 03613720272571, Lot Numbers:  18I0494;  v) B247C10062410, GTIN 03613720272588, Lot Numbers:  18D0968, 18I0584, 18L0089, 20A0451;  w) B247C10062810, GTIN 03613720272595, Lot Numbers:  18H0612, 18H0612/1, 18H0612/2;  x) B247C10063210, GTIN 03613720272601, Lot Numbers:  18I0495;  y) B247C11062410, GTIN 03613720272618, Lot Numbers:  18D0969, 18I0586, 19F0265;  z) B247C11062810, GTIN 03613720272625, Lot Numbers:  18H0613, 18H0613/1;  aa) B247C11063210, GTIN 03613720272632, Lot Numbers:  18I0496;  bb) B247C12062410, GTIN 03613720272649, Lot Numbers:  18D0970;  cc) B247C12062810, GTIN 03613720272656, Lot Numbers:  18H0614, 18I0558;  dd) B247C12063210, GTIN 03613720272663, Lot Numbers:  18I0560;  ee) B247C13062410, GTIN 03613720272670, Lot Numbers:  18I0589;  ff) B247C13062810, GTIN 03613720272687, Lot Numbers:  18H0615;  gg) B247C13063210, GTIN 03613720272694, Lot Numbers:  18I0561;  hh) B247C14062410, GTIN 03613720272700, Lot Numbers:  18L0099;  ii) B247C14062810, GTIN 03613720272717, Lot Numbers:  18H0616/1/1, 18H0616/2;  jj) B247C14063210, GTIN 03613720272724, Lot Numbers:  18I0562;  kk) B247C15062810, GTIN 03613720272748, Lot Numbers:  18I0498;  ll) B247C15063210, GTIN 03613720272755, Lot Numbers:  18I0563",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US nationwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}