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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2462-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "IMPIX MANTA+, REF numbers:    a) B20171743,   b) B20171753,   c) B20171763,   d) B20171773,   e) B20171943,   f) B20171953,   g) B20171963,   h) B20171973,   i) B20172253,   j) B20172263,   k) B20172273; intervertebral fusion device - cervical",
  "description": "FDA recall Z-2462-2023 — Medicrea International is recalling IMPIX MANTA+, REF numbers:    a) B20171743,   b) B20171753,   c) B20171763,   d) B20171773,   e) B20171943,   f) B20171953,   g) B20171963,   h) B20171973,   i) B20172253,   j) B20172263,   k) B20172273; 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.",
  "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": {
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      "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-2462-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "IMPIX MANTA+, REF numbers:    a) B20171743,   b) B20171753,   c) B20171763,   d) B20171773,   e) B20171943,   f) B20171953,   g) B20171963,   h) B20171973,   i) B20172253,   j) B20172263,   k) B20172273; intervertebral fusion device - cervical",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medicrea International"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2462-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2462-2023: Medicrea International is recalling IMPIX MANTA+, REF numbers:    a) B20171743,   b) B20171753,   c) B20171763,   d) B20171773,   e) B20171943,   f) B20171953,   g) B20171963,   h) B20171973,   i) B20172253,   j) B20172263,   k) B20172273; intervertebral fusion device - cervical",
      "text": "The FDA logged enforcement record Z-2462-2023: Medicrea International is voluntarily recalling IMPIX MANTA+, REF numbers:    a) B20171743,   b) B20171753,   c) B20171763,   d) B20171773,   e) B20171943,   f) B20171953,   g) B20171963,   h) B20171973,   i) B20172253,   j) B20172263,   k) B20172273; 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) B20171743, GTIN 03613720232636, Lot Numbers:  18E0275, 18E0404, 18E0676, 18E0833, 18I0867, 18K0143, 18L0219, 19A0463, 19A0669, 19B0870, 19D0484, 19G0192, 19G0422, 19J0468, 19L0381, 20F0631, 20G0849, 20H0596, 20H0597, 20H0598, 20I0875, 20J0772, 21I0163, 22A0172, 22D0807, 22E0264, 22G0048, 22G0477, 22I0342;  b) B20171753, GTIN 03613720232667, Lot Numbers:  18H0597, 18K0137, 18K0831, 18L0488, 19A0324, 19A0325, 19B0362, 19B0470, 19D0485, 19E0322, 19G0204, 19G0423, 19I0274, 19J0273, 19L0382, 20F0632, 20F0633, 20H0600, 20H0601, 20H0602, 20H0603, 20I0222, 21C0104, 21F0651, 21I0511, 22I0615, 22J0265;  c) B20171763, GTIN 03613720232698, Lot Numbers:  18E0405, 18E0834, 18G0422, 18H0572, 18J0063, 18K0066, 18L0070, 18L0489, 19A0215, 19A0425, 19B0687, 19C0653, 19D0486, 19E0436, 19G0830, 19I0842, 19L0383, 20F0634, 20H0594, 20H0595, 21E0234, 21G0482, 22I0343;  d) B20171773, GTIN 03613720232728, Lot Numbers:  19C0591, 19F0579, 19H0089, 19J0272, 20F0635, 20H0249, 22G0571;  e) B20171943, GTIN 03613720232841, Lot Numbers:  18C0552, 18E0835, 18I0712, 18K0897, 18L0490, 19A0670, 19B0680, 19D0251, 19G0302, 19I0582, 20A0644, 20F0636, 20H0599, 20I0487, 21H0101, 22A0173, 22B0482, 22D0808, 22E0808;  f) B20171953, GTIN 03613720232872, Lot Numbers:  18E0483, 18E0677, 18E0836, 18J0103, 18K0144, 18L0400, 19A0159, 19A0671, 19A0675, 19B0089, 19D0487, 19D0637, 19F0103, 19G0303, 19H0375, 19I0843, 19K0586, 20A0200, 20C0163, 20F0637, 20H0251, 20H0254, 20H0255, 20J0062, 20J0065, 20J0368, 21F0551, 21I0177, 22B0786, 22E0263, 22E0809, 22F0490, 22F0492, 22G0440, 22H0055, 22J0202;  g) B20171963, GTIN 03613720232902, Lot Numbers:  18K0158, 18L0491, 19A0672, 19A0829, 19C0146, 19D0262, 19E0437, 19G0424, 19H0376, 19I0234, 19K0832, 19L0613, 20A0969, 20F0638, 20H0604, 20H0605, 20H0606, 20H0607, 20I0705, 20J0068, 21F0155, 22D0809, 22G0441, 22H0643, 22J0203,;  h) B20171973, GTIN 03613720232933, Lot Numbers:  18D0171, 18F0203, 18I0466, 18K0136, 18L0492, 19A0673, 19D0488, 19I0844, 20H0257, 21A0064, 22D0385, 22F1090, 22G0442;  i) B20172253, GTIN 03613720233084, Lot Numbers:  18E0406, 18K0140, 18K0898, 19A0214, 19B0174, 19C0728, 19E0438, 19I0583, 20H0258, 20K0542, 21G0760;  j) B20172263, GTIN 03613720233114, Lot Numbers:  18D1078, 18G0423, 18K0159, 18L0220, 19A0069, 19B0175, 19E0439, 19I0845, 20A0995, 20F0386, 20H0593, 20J0127, 21F0247, 21J0503;  k) B20172273, GTIN 03613720233145, Lot Numbers:  18K0160, 18K0608, 19A0079, 19B0471, 19C0729, 19D0671, 19J0469, 20H0259, 22B0180, 22B0484, 22E0095. 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-2462-2023&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-2462-2023&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-2462-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2462-2023 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-2462-2023&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-2462-2023&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-2462-2023/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."
    }
  ],
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      "name": "FDA recall details — Z-2462-2023",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2462-2023",
            "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) B20171743, GTIN 03613720232636, Lot Numbers:  18E0275, 18E0404, 18E0676, 18E0833, 18I0867, 18K0143, 18L0219, 19A0463, 19A0669, 19B0870, 19D0484, 19G0192, 19G0422, 19J0468, 19L0381, 20F0631, 20G0849, 20H0596, 20H0597, 20H0598, 20I0875, 20J0772, 21I0163, 22A0172, 22D0807, 22E0264, 22G0048, 22G0477, 22I0342;  b) B20171753, GTIN 03613720232667, Lot Numbers:  18H0597, 18K0137, 18K0831, 18L0488, 19A0324, 19A0325, 19B0362, 19B0470, 19D0485, 19E0322, 19G0204, 19G0423, 19I0274, 19J0273, 19L0382, 20F0632, 20F0633, 20H0600, 20H0601, 20H0602, 20H0603, 20I0222, 21C0104, 21F0651, 21I0511, 22I0615, 22J0265;  c) B20171763, GTIN 03613720232698, Lot Numbers:  18E0405, 18E0834, 18G0422, 18H0572, 18J0063, 18K0066, 18L0070, 18L0489, 19A0215, 19A0425, 19B0687, 19C0653, 19D0486, 19E0436, 19G0830, 19I0842, 19L0383, 20F0634, 20H0594, 20H0595, 21E0234, 21G0482, 22I0343;  d) B20171773, GTIN 03613720232728, Lot Numbers:  19C0591, 19F0579, 19H0089, 19J0272, 20F0635, 20H0249, 22G0571;  e) B20171943, GTIN 03613720232841, Lot Numbers:  18C0552, 18E0835, 18I0712, 18K0897, 18L0490, 19A0670, 19B0680, 19D0251, 19G0302, 19I0582, 20A0644, 20F0636, 20H0599, 20I0487, 21H0101, 22A0173, 22B0482, 22D0808, 22E0808;  f) B20171953, GTIN 03613720232872, Lot Numbers:  18E0483, 18E0677, 18E0836, 18J0103, 18K0144, 18L0400, 19A0159, 19A0671, 19A0675, 19B0089, 19D0487, 19D0637, 19F0103, 19G0303, 19H0375, 19I0843, 19K0586, 20A0200, 20C0163, 20F0637, 20H0251, 20H0254, 20H0255, 20J0062, 20J0065, 20J0368, 21F0551, 21I0177, 22B0786, 22E0263, 22E0809, 22F0490, 22F0492, 22G0440, 22H0055, 22J0202;  g) B20171963, GTIN 03613720232902, Lot Numbers:  18K0158, 18L0491, 19A0672, 19A0829, 19C0146, 19D0262, 19E0437, 19G0424, 19H0376, 19I0234, 19K0832, 19L0613, 20A0969, 20F0638, 20H0604, 20H0605, 20H0606, 20H0607, 20I0705, 20J0068, 21F0155, 22D0809, 22G0441, 22H0643, 22J0203,;  h) B20171973, GTIN 03613720232933, Lot Numbers:  18D0171, 18F0203, 18I0466, 18K0136, 18L0492, 19A0673, 19D0488, 19I0844, 20H0257, 21A0064, 22D0385, 22F1090, 22G0442;  i) B20172253, GTIN 03613720233084, Lot Numbers:  18E0406, 18K0140, 18K0898, 19A0214, 19B0174, 19C0728, 19E0438, 19I0583, 20H0258, 20K0542, 21G0760;  j) B20172263, GTIN 03613720233114, Lot Numbers:  18D1078, 18G0423, 18K0159, 18L0220, 19A0069, 19B0175, 19E0439, 19I0845, 20A0995, 20F0386, 20H0593, 20J0127, 21F0247, 21J0503;  k) B20172273, GTIN 03613720233145, Lot Numbers:  18K0160, 18K0608, 19A0079, 19B0471, 19C0729, 19D0671, 19J0469, 20H0259, 22B0180, 22B0484, 22E0095",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US nationwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}