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  "name": "Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix",
  "description": "FDA recall Z-0166-2024 — Medtronic Sofamor Danek USA Inc is recalling Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix (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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    "name": "Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix",
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      "name": "FDA recall Z-0166-2024: Medtronic Sofamor Danek USA Inc is recalling Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix",
      "text": "The FDA logged enforcement record Z-0166-2024: Medtronic Sofamor Danek USA Inc is voluntarily recalling Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix — reason: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-26. Affected lots/codes: a) T45001:  GTIN 00643169122949, Serial Numbers:  A48245-111, A58751-114, A57260-060, A57260-063, A58751-112, A58751-113, A57260-083, A57260-084, A58428-149, A58428-150, A57260-082, A58428-148, A58751-111, A57260-078, A58428-141, A48245-075, A48245-076, A57260-075, A58751-096, A57260-079, A58428-147, A58428-128, A57260-072, A57260-059, A57260-067, A57260-068, A57260-069, A48245-105, A48245-106, A57256-160, A58751-100, A57256-161, A48245-113, A57256-164, A58799-167, A58799-168, A58799-169, A58799-170, A58799-171, A57256-170, A48245-107, A48245-108, A57256-136, A58751-108, A48245-079, A48245-082, A48245-083, A48245-084, A48245-086, A58751-070, A58751-071, A58751-072, A58751-073, A58751-074, A58751-075, A58751-076, A58751-115, A58799-087, A48245-101, A58799-165, A58799-166, A48245-032, A48245-033, A48245-034, A48245-035, A48245-036, A57260-058, A58799-143, A58799-144, A48245-098, A48245-099, A58428-099, A58428-100, A58428-101, A58428-102, A58428-103, A57260-061, A48245-026, A48245-100, A48245-027, A48245-028, A48245-029, A48245-030, A48245-031, A58751-077, A58751-078, A58751-079, A58751-080, A57260-064, A57260-065, A57260-066, A58428-086, A58428-087, A58428-088, A57256-145, A57256-146, A57256-147, A57256-148, A57256-149, A57256-150, A48245-018, A58799-099, A58799-100, A58799-113, A58799-114, A48245-053, A58799-123, A48245-080, A48245-081, A58428-107, A58428-108, A58428-109, A58428-110, A57256-137, A57256-138, A57256-139, A57256-140, A58799-107, A58799-108, A58799-109, A58751-083, A58751-084, A58751-085, A48245-022, A48245-023, A58428-111, A58428-112, A58428-113, A58428-114, A58751-086, A58751-087, A58751-088, A58751-089, A57256-172, A58428-115, A58428-116, A58799-119, A58799-120, A58799-124, A58799-125, A48245-037, A48245-038, A57256-133, A57256-134, A57256-135, A57256-142, A57256-143, A57256-144, A58751-081, A58799-172, A58799-173, A58799-174, A58799-175, A58799-176, A58799-177, A58799-092, A58799-093, A58428-117, A58428-118, A48245-019, A48245-020, A48245-021, A58799-128, A58799-129, A58799-130, A58799-131, A58799-132, A48245-087, A48245-088, A57260-080, A57260-081, A58428-119, A58799-134, A58751-090, A48245-042, A48245-043, A48245-095, A48245-096, A48245-097, A58428-120, A58428-121, A58428-122, A58751-091, A58799-135, A58799-136, A58799-137, A58799-138, A58799-139, A48245-074, A48245-094, A48245-044, A48245-045, A48245-046, A58751-093, A58751-094, A58751-095, A58428-123, A58428-124, A58428-125, A58428-144, A58428-145, A58428-146, A48245-085, A48245-116, A48245-039, A48245-040, A48245-041, A58428-104, A58428-105, A58428-106, A58799-102, A58799-103, A58799-104, A58799-105, A48245-089, A48245-090, A48245-091, A48245-092, A48245-093, A48245-077, A57260-076, A57260-077, A58428-126, A58428-127, A58799-121, A58799-122, A58799-126, A58799-127, A58799-094, A58799-095, A48245-112, A58751-097, A58751-092, A58799-097, A58799-098, A58428-130, A58428-131, A58428-132, A58428-133, A58428-134, A57260-073, A57260-074, A58799-088, A58799-089, A58799-090, A58799-091, A58799-140, A58799-141, A58799-142, A58799-145, A58799-146, A58799-147, A58799-148, A58799-149, A58799-150, A58799-151, A58799-152, A58799-153, A58799-154, A58799-155, A58799-156, A58799-157, A58799-158, A58799-159, A58799-160, A58799-161, A58799-162, A57256-171, A48245-054, A48245-055, A58751-098, A58751-099, A48245-117, A48245-118, A48245-119, A48245-120, A57260-070, A57260-071, A48245-102, A58799-101, A58799-163, A58799-164, A58799-106, A58799-110, A58799-111, A58799-112, A58799-115, A58799-116, A58799-117, A58799-118, A57256-141, A58428-139, A48245-109, A48245-110, A57256-157, A57256-158, A57256-159, A48245-114, A48245-115, A48245-056, A48245-057, A48245-068, A48245-069, A48245-070, A48245-071, A48245-072, A48245-073, A48245-078, A58751-101, A58751-102, A58751-103, A58751-104, A58751-105, A48245-048, A48245-049, A48245-050, A48245-051, A48245-052, A58428-090, A58428-091, A58428-092, A58428-093, A58428-135, A58428-136, A58751-106, A58799-133, A58751-109, A58751-110, A58751-082, A58799-096, A57256-162, A57256-163, A58428-142, A48245-058, A58428-129, A57256-165, A48245-024, A48245-025, A58428-089, A58428-143, A58751-067, A58751-068, A58751-069, A57256-166, A58428-140, A48245-047, A58428-137, A58428-138, A57256-151, A57256-152, A57256-153, A57256-154, A57256-155, A57256-156, A58428-094, A58428-095, A58428-096, A58428-097, A58428-098, A48245-059, A48245-060, A48245-061, A48245-062, A48245-063, A48245-064, A48245-065, A48245-066, A48245-067, A57260-062, A58751-107, A57256-167, A57256-168, A57256-169, A48245-103, A48245-104;   b) T45005:  GTIN 00643169123021, Serial Numbers:  A58746-016, A57923-013, A59083-037, A57923-022, A57878-072, A58720-014, A58720-015, A57261-045, A57261-046, A57261-047, A59083-048, A58973-023, A58973-024, A58973-025, A58973-026, A58973-027, A59132-021, A59132-022, A59132-023, A59132-024, A59132-025, A59132-026, A59132-027, A59132-028, A59132-029, A59132-030, A57878-063, A57878-064, A57878-065, A57878-066, A57878-067, A58973-029, A58973-033, A58746-013, A58746-015, A58746-014, A57923-021, A59083-049, A57923-011, A57923-012, A58746-018, A58746-019, A58746-020, A58746-021, A58746-024, A57878-068, A57878-069, A58973-028, A58746-023, A58746-025, A58746-029, A58746-030, A58746-031, A58746-032, A57878-070, A57878-071, A58746-026, A58746-027, A57923-014, A57923-015, A57261-039, A57261-040, A57261-041, A57261-042, A57261-043, A57261-044, A58746-028, A59083-036, A59083-038, A58746-011, A58746-012, A58746-017, A58973-011, A58973-012, A58973-013, A58973-014, A58973-015, A58973-016, A58973-017, A58973-018, A58973-019, A58973-020, A58973-021, A58973-022, A58720-023, A57878-073, A57878-074, A57261-038, A59083-039, A59083-040, A59083-041, A57261-056, A57878-075, A57878-076, A57261-048, A57261-049, A57261-050, A58720-011, A58720-012, A57261-051, A57261-052, A59083-042, A57261-055, A57261-057, A59083-043, A57261-053, A57261-054, A58720-013, A58720-016, A58720-017, A59083-044, A57923-016, A57923-017, A57923-018, A57923-023, A58973-030, A58973-031, A59083-045, A59129-032, A59129-041, A57923-019, A58720-018, A58720-019, A58720-020, A58720-021, A58720-022, A58973-032, A57923-020, A59083-046, A59083-047, A58746-022, A59132-011, A59132-012, A59132-013, A59132-014, A59132-015, A59132-016, A59132-017, A59132-018, A59132-019, A59132-020;   c) T45010:  GTIN 00643169123038, Serial Numbers:  A59231-018, A59231-019, A56269-064, A59231-014, A56269-066, A59010-019, A59010-021, A59010-022, A59010-023, A56269-071, A56269-072, A59356-017, A59356-018, A59131-019, A59131-020, A59191-026, A59231-020, A59231-015, A59231-016, A59231-017, A59010-024, A59010-025, A56269-065, A59131-011, A59131-012, A59131-013, A59356-011, A59356-012, A59356-013, A59231-013, A56269-061, A56269-062, A56269-063, A59010-026, A59010-027, A59131-014, A59131-015, A59131-016, A59131-017, A59131-018, A59191-027, A59191-028, A59191-029, A59191-030, A59191-031, A59191-032, A59191-033, A59010-020, A56269-067, A56269-068, A59191-034, A59191-035, A59191-036, A59356-020, A59191-037, A59231-011, A59356-019, A56269-069, A56269-070, A59010-016, A59010-017, A59231-012, A59356-014, A59356-015, A56269-060, A59010-018, A59356-016. A RECORDED FDA enforcement action (occurred=true).",
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      "epistemicStatus": {
        "occurred": true,
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        "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-0166-2024&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-0166-2024&lang=eng"
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      "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-0166-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0166-2024 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",
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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-0166-2024&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-0166-2024&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-0166-2024/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.",
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        "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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            "Status": "recorded"
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            "Value": "Devices",
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "item": {
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            "Value": "Medtronic Sofamor Danek USA Inc",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-09-26",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) T45001:  GTIN 00643169122949, Serial Numbers:  A48245-111, A58751-114, A57260-060, A57260-063, A58751-112, A58751-113, A57260-083, A57260-084, A58428-149, A58428-150, A57260-082, A58428-148, A58751-111, A57260-078, A58428-141, A48245-075, A48245-076, A57260-075, A58751-096, A57260-079, A58428-147, A58428-128, A57260-072, A57260-059, A57260-067, A57260-068, A57260-069, A48245-105, A48245-106, A57256-160, A58751-100, A57256-161, A48245-113, A57256-164, A58799-167, A58799-168, A58799-169, A58799-170, A58799-171, A57256-170, A48245-107, A48245-108, A57256-136, A58751-108, A48245-079, A48245-082, A48245-083, A48245-084, A48245-086, A58751-070, A58751-071, A58751-072, A58751-073, A58751-074, A58751-075, A58751-076, A58751-115, A58799-087, A48245-101, A58799-165, A58799-166, A48245-032, A48245-033, A48245-034, A48245-035, A48245-036, A57260-058, A58799-143, A58799-144, A48245-098, A48245-099, A58428-099, A58428-100, A58428-101, A58428-102, A58428-103, A57260-061, A48245-026, A48245-100, A48245-027, A48245-028, A48245-029, A48245-030, A48245-031, A58751-077, A58751-078, A58751-079, A58751-080, A57260-064, A57260-065, A57260-066, A58428-086, A58428-087, A58428-088, A57256-145, A57256-146, A57256-147, A57256-148, A57256-149, A57256-150, A48245-018, A58799-099, A58799-100, A58799-113, A58799-114, A48245-053, A58799-123, A48245-080, A48245-081, A58428-107, A58428-108, A58428-109, A58428-110, A57256-137, A57256-138, A57256-139, A57256-140, A58799-107, A58799-108, A58799-109, A58751-083, A58751-084, A58751-085, A48245-022, A48245-023, A58428-111, A58428-112, A58428-113, A58428-114, A58751-086, A58751-087, A58751-088, A58751-089, A57256-172, A58428-115, A58428-116, A58799-119, A58799-120, A58799-124, A58799-125, A48245-037, A48245-038, A57256-133, A57256-134, A57256-135, A57256-142, A57256-143, A57256-144, A58751-081, A58799-172, A58799-173, A58799-174, A58799-175, A58799-176, A58799-177, A58799-092, A58799-093, A58428-117, A58428-118, A48245-019, A48245-020, A48245-021, A58799-128, A58799-129, A58799-130, A58799-131, A58799-132, A48245-087, A48245-088, A57260-080, A57260-081, A58428-119, A58799-134, A58751-090, A48245-042, A48245-043, A48245-095, A48245-096, A48245-097, A58428-120, A58428-121, A58428-122, A58751-091, A58799-135, A58799-136, A58799-137, A58799-138, A58799-139, A48245-074, A48245-094, A48245-044, A48245-045, A48245-046, A58751-093, A58751-094, A58751-095, A58428-123, A58428-124, A58428-125, A58428-144, A58428-145, A58428-146, A48245-085, A48245-116, A48245-039, A48245-040, A48245-041, A58428-104, A58428-105, A58428-106, A58799-102, A58799-103, A58799-104, A58799-105, A48245-089, A48245-090, A48245-091, A48245-092, A48245-093, A48245-077, A57260-076, A57260-077, A58428-126, A58428-127, A58799-121, A58799-122, A58799-126, A58799-127, A58799-094, A58799-095, A48245-112, A58751-097, A58751-092, A58799-097, A58799-098, A58428-130, A58428-131, A58428-132, A58428-133, A58428-134, A57260-073, A57260-074, A58799-088, A58799-089, A58799-090, A58799-091, A58799-140, A58799-141, A58799-142, A58799-145, A58799-146, A58799-147, A58799-148, A58799-149, A58799-150, A58799-151, A58799-152, A58799-153, A58799-154, A58799-155, A58799-156, A58799-157, A58799-158, A58799-159, A58799-160, A58799-161, A58799-162, A57256-171, A48245-054, A48245-055, A58751-098, A58751-099, A48245-117, A48245-118, A48245-119, A48245-120, A57260-070, A57260-071, A48245-102, A58799-101, A58799-163, A58799-164, A58799-106, A58799-110, A58799-111, A58799-112, A58799-115, A58799-116, A58799-117, A58799-118, A57256-141, A58428-139, A48245-109, A48245-110, A57256-157, A57256-158, A57256-159, A48245-114, A48245-115, A48245-056, A48245-057, A48245-068, A48245-069, A48245-070, A48245-071, A48245-072, A48245-073, A48245-078, A58751-101, A58751-102, A58751-103, A58751-104, A58751-105, A48245-048, A48245-049, A48245-050, A48245-051, A48245-052, A58428-090, A58428-091, A58428-092, A58428-093, A58428-135, A58428-136, A58751-106, A58799-133, A58751-109, A58751-110, A58751-082, A58799-096, A57256-162, A57256-163, A58428-142, A48245-058, A58428-129, A57256-165, A48245-024, A48245-025, A58428-089, A58428-143, A58751-067, A58751-068, A58751-069, A57256-166, A58428-140, A48245-047, A58428-137, A58428-138, A57256-151, A57256-152, A57256-153, A57256-154, A57256-155, A57256-156, A58428-094, A58428-095, A58428-096, A58428-097, A58428-098, A48245-059, A48245-060, A48245-061, A48245-062, A48245-063, A48245-064, A48245-065, A48245-066, A48245-067, A57260-062, A58751-107, A57256-167, A57256-168, A57256-169, A48245-103, A48245-104;   b) T45005:  GTIN 00643169123021, Serial Numbers:  A58746-016, A57923-013, A59083-037, A57923-022, A57878-072, A58720-014, A58720-015, A57261-045, A57261-046, A57261-047, A59083-048, A58973-023, A58973-024, A58973-025, A58973-026, A58973-027, A59132-021, A59132-022, A59132-023, A59132-024, A59132-025, A59132-026, A59132-027, A59132-028, A59132-029, A59132-030, A57878-063, A57878-064, A57878-065, A57878-066, A57878-067, A58973-029, A58973-033, A58746-013, A58746-015, A58746-014, A57923-021, A59083-049, A57923-011, A57923-012, A58746-018, A58746-019, A58746-020, A58746-021, A58746-024, A57878-068, A57878-069, A58973-028, A58746-023, A58746-025, A58746-029, A58746-030, A58746-031, A58746-032, A57878-070, A57878-071, A58746-026, A58746-027, A57923-014, A57923-015, A57261-039, A57261-040, A57261-041, A57261-042, A57261-043, A57261-044, A58746-028, A59083-036, A59083-038, A58746-011, A58746-012, A58746-017, A58973-011, A58973-012, A58973-013, A58973-014, A58973-015, A58973-016, A58973-017, A58973-018, A58973-019, A58973-020, A58973-021, A58973-022, A58720-023, A57878-073, A57878-074, A57261-038, A59083-039, A59083-040, A59083-041, A57261-056, A57878-075, A57878-076, A57261-048, A57261-049, A57261-050, A58720-011, A58720-012, A57261-051, A57261-052, A59083-042, A57261-055, A57261-057, A59083-043, A57261-053, A57261-054, A58720-013, A58720-016, A58720-017, A59083-044, A57923-016, A57923-017, A57923-018, A57923-023, A58973-030, A58973-031, A59083-045, A59129-032, A59129-041, A57923-019, A58720-018, A58720-019, A58720-020, A58720-021, A58720-022, A58973-032, A57923-020, A59083-046, A59083-047, A58746-022, A59132-011, A59132-012, A59132-013, A59132-014, A59132-015, A59132-016, A59132-017, A59132-018, A59132-019, A59132-020;   c) T45010:  GTIN 00643169123038, Serial Numbers:  A59231-018, A59231-019, A56269-064, A59231-014, A56269-066, A59010-019, A59010-021, A59010-022, A59010-023, A56269-071, A56269-072, A59356-017, A59356-018, A59131-019, A59131-020, A59191-026, A59231-020, A59231-015, A59231-016, A59231-017, A59010-024, A59010-025, A56269-065, A59131-011, A59131-012, A59131-013, A59356-011, A59356-012, A59356-013, A59231-013, A56269-061, A56269-062, A56269-063, A59010-026, A59010-027, A59131-014, A59131-015, A59131-016, A59131-017, A59131-018, A59191-027, A59191-028, A59191-029, A59191-030, A59191-031, A59191-032, A59191-033, A59010-020, A56269-067, A56269-068, A59191-034, A59191-035, A59191-036, A59356-020, A59191-037, A59231-011, A59356-019, A56269-069, A56269-070, A59010-016, A59010-017, A59231-012, A59356-014, A59356-015, A56269-060, A59010-018, A59356-016",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US, Colombia, S. Korea, New Zealand, India, Taiwan",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}