{
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    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2458-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "PASS LP, REF numbers:    a) B02315535Z,   b) B02315540Z,   c) B02315545Z,   d) B02315550Z,   e) B02316535Z,   f) B02316540Z,   g) B02316545Z,   h) B02316550Z,   i) B02317540Z,   j) B02317545Z,   k) B02317550Z; intervertebral fusion device - cervical",
  "description": "FDA recall Z-2458-2023 — Medicrea International is recalling PASS LP, REF numbers:    a) B02315535Z,   b) B02315540Z,   c) B02315545Z,   d) B02315550Z,   e) B02316535Z,   f) B02316540Z,   g) B02316545Z,   h) B02316550Z,   i) B02317540Z,   j) B02317545Z,   k) B02317550Z; 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/",
  "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-2458-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "PASS LP, REF numbers:    a) B02315535Z,   b) B02315540Z,   c) B02315545Z,   d) B02315550Z,   e) B02316535Z,   f) B02316540Z,   g) B02316545Z,   h) B02316550Z,   i) B02317540Z,   j) B02317545Z,   k) B02317550Z; intervertebral fusion device - cervical",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medicrea International"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2458-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2458-2023: Medicrea International is recalling PASS LP, REF numbers:    a) B02315535Z,   b) B02315540Z,   c) B02315545Z,   d) B02315550Z,   e) B02316535Z,   f) B02316540Z,   g) B02316545Z,   h) B02316550Z,   i) B02317540Z,   j) B02317545Z,   k) B02317550Z; intervertebral fusion device - cervical",
      "text": "The FDA logged enforcement record Z-2458-2023: Medicrea International is voluntarily recalling PASS LP, REF numbers:    a) B02315535Z,   b) B02315540Z,   c) B02315545Z,   d) B02315550Z,   e) B02316535Z,   f) B02316540Z,   g) B02316545Z,   h) B02316550Z,   i) B02317540Z,   j) B02317545Z,   k) B02317550Z; 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) B02315535Z, GTIN 03613720185086, Lot Numbers:  21J0184;  b) B02315540Z, GTIN 03613720185116, Lot Numbers:  18E0322, 18F1011, 18G0704, 18I0780, 18K0862, 19B0091, 19B0731, 19D0267, 19F0460, 19J0742, 20A0966, 20F0008, 20I0200, 20I0833, 22I0616;  c) B02315545Z, GTIN 03613720185147, Lot Numbers:  18H0617, 18I0682, 18J0215, 18K0863, 19K0545, 20H0147;  d) B02315550Z, GTIN 03613720185178, Lot Numbers:  19E0306, 20F0009;  e) B02316535Z, GTIN 03613720185321, Lot Numbers:  21J0185, 21J0899;  f) B02316540Z, GTIN 03613720185352, Lot Numbers:  18E0478, 18H0672, 18K0278, 18K0864, 19A0645, 19B0318, 19B0777, 19C0417, 19C0739, 19E0082, 19I0573, 20A0596, 20B0687, 20H0148, 20J0414, 21A0107, 22A0297, 22I0339;  g) B02316545Z, GTIN 03613720185383, Lot Numbers:  18D1035, 18E0508, 18F0534, 18G0170, 18G0591, 18H0588, 18J0054, 18K0279, 18K0865, 19A0066, 19B0093, 19B0912, 19C0138, 19D0177, 19E0084, 19G0188, 19J0227, 19J0228, 19K0764, 19L0360, 19L0580, 20B0688, 20H0151, 20J0415, 20L0238, 21A0109, 21A0642, 21D0174, 21F0505, 21L0394, 22A0047, 22L0091;  h) B02316550Z, GTIN 03613720185413, Lot Numbers:  21A0506, 21C0501;  i) B02317540Z, GTIN 03613720185598, Lot Numbers:  21A0110, 21A0508, 21A0524, 22B0782;  j) B02317545Z, GTIN 03613720185628, Lot Numbers:  20E0097, 21A0076, 21B0498;  k) B02317550Z, GTIN 03613720185659, Lot Numbers:  20C0294, 20H0508, 20J0283, 22B0366. 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-2458-2023&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-2458-2023&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-2458-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2458-2023 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-2458-2023&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-2458-2023&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-2458-2023/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-2458-2023",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2458-2023",
            "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) B02315535Z, GTIN 03613720185086, Lot Numbers:  21J0184;  b) B02315540Z, GTIN 03613720185116, Lot Numbers:  18E0322, 18F1011, 18G0704, 18I0780, 18K0862, 19B0091, 19B0731, 19D0267, 19F0460, 19J0742, 20A0966, 20F0008, 20I0200, 20I0833, 22I0616;  c) B02315545Z, GTIN 03613720185147, Lot Numbers:  18H0617, 18I0682, 18J0215, 18K0863, 19K0545, 20H0147;  d) B02315550Z, GTIN 03613720185178, Lot Numbers:  19E0306, 20F0009;  e) B02316535Z, GTIN 03613720185321, Lot Numbers:  21J0185, 21J0899;  f) B02316540Z, GTIN 03613720185352, Lot Numbers:  18E0478, 18H0672, 18K0278, 18K0864, 19A0645, 19B0318, 19B0777, 19C0417, 19C0739, 19E0082, 19I0573, 20A0596, 20B0687, 20H0148, 20J0414, 21A0107, 22A0297, 22I0339;  g) B02316545Z, GTIN 03613720185383, Lot Numbers:  18D1035, 18E0508, 18F0534, 18G0170, 18G0591, 18H0588, 18J0054, 18K0279, 18K0865, 19A0066, 19B0093, 19B0912, 19C0138, 19D0177, 19E0084, 19G0188, 19J0227, 19J0228, 19K0764, 19L0360, 19L0580, 20B0688, 20H0151, 20J0415, 20L0238, 21A0109, 21A0642, 21D0174, 21F0505, 21L0394, 22A0047, 22L0091;  h) B02316550Z, GTIN 03613720185413, Lot Numbers:  21A0506, 21C0501;  i) B02317540Z, GTIN 03613720185598, Lot Numbers:  21A0110, 21A0508, 21A0524, 22B0782;  j) B02317545Z, GTIN 03613720185628, Lot Numbers:  20E0097, 21A0076, 21B0498;  k) B02317550Z, GTIN 03613720185659, Lot Numbers:  20C0294, 20H0508, 20J0283, 22B0366",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US nationwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}