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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1323-2023.jsonld",
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  "name": "Medtronic Grafton Putty:    a)\tDBM S43101 GRAFTON 0.5CC PUTTY, REF S43101;    b)\tDBM S43102 GRAFTON 1CC PUTTY, REF S43102;    c)\tDBM S43103 GRAFTON 2.5CC PUTTY, REF S43103;    d)\tDBM S43105 GRAFTON 5CC PUTTY, REF S43105;    e)\tDBM S43110 GRAFTON 10CC PUTTY, REF S43110;    f)\tDBM T43101 0.5CC GRAFTON PUTTY, REF T43101;    g)\tDBM T43101INT 0.5CC GRAFTON PUTTY, REF T43101INT;  h)\tDBM T43102 1CC GRAFTON PUTTY, REF T43102;    i)\tDBM T43102INT 1CC GRAFTON PUTTY, REF T43102INT;    j)\tDBM T43102JPN GRAFTON PUTTY 1CC JAR, REF T43102JPN;    k)\tDBM T43103 2.5CC GRAFTON PUTTY, REF T43103;    l)\tDBM T43103INT 2.5CC GRAFTON PUTTY, REF T43103INT;    m)\tDBM T43103JPN GRAFTON PUTTY 2.5CC JAR, REF T43103JPN;    n)\tDBM T43105 5CC GRAFTON PUTTY, REF T43105;    o)\tDBM T43105INT 5CC GRAFTON PUTTY, REF T43105INT;    p)\tDBM T43105JPN GRAFTON PUTTY 5CC JAR, REF T43105JPN;    q)\tDBM T43110 10CC GRAFTON PUTTY, REF T43110;   r)\tDBM T43110INT 10CC GRAFTON PUTTY, REF T43110INT;   Demineralized Bone Matrix (DBM) product",
  "description": "FDA recall Z-1323-2023 — Medtronic Sofamor Danek USA Inc is recalling Medtronic Grafton Putty:    a)\tDBM S43101 GRAFTON 0.5CC PUTTY, REF S43101;    b)\tDBM S43102 GRAFTON 1CC PUTTY, REF S43102;    c)\tDBM S43103 GRAFTON 2.5CC PUTTY, REF S43103;    d)\tDBM S43105 GRAFTON 5CC PUTTY, REF S43105;    e)\tDBM S43110 GRAFTON 10CC PUTTY, REF S43110;    f)\tDBM T43101 0.5CC GRAFTON PUTTY, REF T43101;    g)\tDBM T43101INT 0.5CC GRAFTON PUTTY, REF T43101INT;  h)\tDBM T43102 1CC GRAFTON PUTTY, REF T43102;    i)\tDBM T43102INT 1CC GRAFTON PUTTY, REF T43102INT;    j)\tDBM T43102JPN GRAFTON PUTTY 1CC JAR, REF T43102JPN;    k)\tDBM T43103 2.5CC GRAFTON PUTTY, REF T43103;    l)\tDBM T43103INT 2.5CC GRAFTON PUTTY, REF T43103INT;    m)\tDBM T43103JPN GRAFTON PUTTY 2.5CC JAR, REF T43103JPN;    n)\tDBM T43105 5CC GRAFTON PUTTY, REF T43105;    o)\tDBM T43105INT 5CC GRAFTON PUTTY, REF T43105INT;    p)\tDBM T43105JPN GRAFTON PUTTY 5CC JAR, REF T43105JPN;    q)\tDBM T43110 10CC GRAFTON PUTTY, REF T43110;   r)\tDBM T43110INT 10CC GRAFTON PUTTY, REF T43110INT;   Demineralized Bone Matrix (DBM) product (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "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-1323-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medtronic Grafton Putty:    a)\tDBM S43101 GRAFTON 0.5CC PUTTY, REF S43101;    b)\tDBM S43102 GRAFTON 1CC PUTTY, REF S43102;    c)\tDBM S43103 GRAFTON 2.5CC PUTTY, REF S43103;    d)\tDBM S43105 GRAFTON 5CC PUTTY, REF S43105;    e)\tDBM S43110 GRAFTON 10CC PUTTY, REF S43110;    f)\tDBM T43101 0.5CC GRAFTON PUTTY, REF T43101;    g)\tDBM T43101INT 0.5CC GRAFTON PUTTY, REF T43101INT;  h)\tDBM T43102 1CC GRAFTON PUTTY, REF T43102;    i)\tDBM T43102INT 1CC GRAFTON PUTTY, REF T43102INT;    j)\tDBM T43102JPN GRAFTON PUTTY 1CC JAR, REF T43102JPN;    k)\tDBM T43103 2.5CC GRAFTON PUTTY, REF T43103;    l)\tDBM T43103INT 2.5CC GRAFTON PUTTY, REF T43103INT;    m)\tDBM T43103JPN GRAFTON PUTTY 2.5CC JAR, REF T43103JPN;    n)\tDBM T43105 5CC GRAFTON PUTTY, REF T43105;    o)\tDBM T43105INT 5CC GRAFTON PUTTY, REF T43105INT;    p)\tDBM T43105JPN GRAFTON PUTTY 5CC JAR, REF T43105JPN;    q)\tDBM T43110 10CC GRAFTON PUTTY, REF T43110;   r)\tDBM T43110INT 10CC GRAFTON PUTTY, REF T43110INT;   Demineralized Bone Matrix (DBM) product",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medtronic Sofamor Danek USA Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1323-2023/enforcement-record",
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      "name": "FDA recall Z-1323-2023: Medtronic Sofamor Danek USA Inc is recalling Medtronic Grafton Putty:    a)\tDBM S43101 GRAFTON 0.5CC PUTTY, REF S43101;    b)\tDBM S43102 GRAFTON 1CC PUTTY, REF S43102;    c)\tDBM S43103 GRAFTON 2.5CC PUTTY, REF S43103;    d)\tDBM S43105 GRAFTON 5CC PUTTY, REF S43105;    e)\tDBM S43110 GRAFTON 10CC PUTTY, REF S43110;    f)\tDBM T43101 0.5CC GRAFTON PUTTY, REF T43101;    g)\tDBM T43101INT 0.5CC GRAFTON PUTTY, REF T43101INT;  h)\tDBM T43102 1CC GRAFTON PUTTY, REF T43102;    i)\tDBM T43102INT 1CC GRAFTON PUTTY, REF T43102INT;    j)\tDBM T43102JPN GRAFTON PUTTY 1CC JAR, REF T43102JPN;    k)\tDBM T43103 2.5CC GRAFTON PUTTY, REF T43103;    l)\tDBM T43103INT 2.5CC GRAFTON PUTTY, REF T43103INT;    m)\tDBM T43103JPN GRAFTON PUTTY 2.5CC JAR, REF T43103JPN;    n)\tDBM T43105 5CC GRAFTON PUTTY, REF T43105;    o)\tDBM T43105INT 5CC GRAFTON PUTTY, REF T43105INT;    p)\tDBM T43105JPN GRAFTON PUTTY 5CC JAR, REF T43105JPN;    q)\tDBM T43110 10CC GRAFTON PUTTY, REF T43110;   r)\tDBM T43110INT 10CC GRAFTON PUTTY, REF T43110INT;   Demineralized Bone Matrix (DBM) product",
      "text": "The FDA logged enforcement record Z-1323-2023: Medtronic Sofamor Danek USA Inc is voluntarily recalling Medtronic Grafton Putty:    a)\tDBM S43101 GRAFTON 0.5CC PUTTY, REF S43101;    b)\tDBM S43102 GRAFTON 1CC PUTTY, REF S43102;    c)\tDBM S43103 GRAFTON 2.5CC PUTTY, REF S43103;    d)\tDBM S43105 GRAFTON 5CC PUTTY, REF S43105;    e)\tDBM S43110 GRAFTON 10CC PUTTY, REF S43110;    f)\tDBM T43101 0.5CC GRAFTON PUTTY, REF T43101;    g)\tDBM T43101INT 0.5CC GRAFTON PUTTY, REF T43101INT;  h)\tDBM T43102 1CC GRAFTON PUTTY, REF T43102;    i)\tDBM T43102INT 1CC GRAFTON PUTTY, REF T43102INT;    j)\tDBM T43102JPN GRAFTON PUTTY 1CC JAR, REF T43102JPN;    k)\tDBM T43103 2.5CC GRAFTON PUTTY, REF T43103;    l)\tDBM T43103INT 2.5CC GRAFTON PUTTY, REF T43103INT;    m)\tDBM T43103JPN GRAFTON PUTTY 2.5CC JAR, REF T43103JPN;    n)\tDBM T43105 5CC GRAFTON PUTTY, REF T43105;    o)\tDBM T43105INT 5CC GRAFTON PUTTY, REF T43105INT;    p)\tDBM T43105JPN GRAFTON PUTTY 5CC JAR, REF T43105JPN;    q)\tDBM T43110 10CC GRAFTON PUTTY, REF T43110;   r)\tDBM T43110INT 10CC GRAFTON PUTTY, REF T43110INT;   Demineralized Bone Matrix (DBM) product — reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a  breach in the sterile barrier.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-08. Affected lots/codes: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101, GTIN 00613994960900, Serial Numbers:  A43107, A44312, A44898, A45026, A47094, A48070, A48239, A48726, A54374;  b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102, GTIN 00613994960894, Serial Numbers:  A39801, A40711, A42973, A43546, A44572, A44970, A45136, A45543, A46181, A46352, A46538, A46924, A47103, A47710, A48122, A48391, A50563, A50858, A51802, A52414, A53427, A54070, A54689, A54892;  c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103, GTIN 00613994960887, Serial Numbers:  A39091, A40452, A41163, A41376, A42289, A43008, A43345, A43555, A45523, A45714, A45746, A46289, A47357, A48134, A48230, A50024, A50343, A51014, A53131, A53706, A54060;  d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105, GTIN 00613994961136, Serial Numbers:  A39669, A41187, A41545, A42539, A42923, A43450, A43481, A43500, A43516, A43853, A43932, A43934, A44475, A44665, A44733, A44805, A44986, A45039, A45175, A45282, A45457, A45552, A45556, A45919, A47043, A47390, A47714, A47833, A47885, A48125, A48540, A48816, A49460, A49472, A50596, A51281, A53513, A53897, A54184, A54492, A54615, A54771, A54892, A54982;  e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110, GTIN 00613994961129, Serial Numbers:  A41514, A41616, A42444, A43082, A43201, A43235, A43608, A43805, A43852, A43925, A43955, A44054, A44267, A45150, A45454, A45474, A45680, A46359, A46622, A47260, A47287, A47525, A48070, A48080, A48092, A48565, A49050, A49411, A49520, A49924, A52108, A52214, A52379, A53417, A53518, A54052, A54164, A54172, A54245, A54678, A54994;   f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101, GTIN 00643169123106, Serial Numbers:  A38151-037, A38151-038, A38151-039, A38151-040, A38151-041, A38151-042, A38151-043, A38151-045, A38151-049, A38151-050, A38151-051, A38151-052, A38151-053, A38151-054, A38151-055, A38151-056, A38151-057, A38151-058, A38151-059, A38151-060, A38151-061, A38151-062, A38151-063, A38151-064, A38151-065, A38151-066, A38151-067, A38151-068, A38151-069, 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      "epistemicStatus": {
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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-1323-2023&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-1323-2023&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."
    },
    {
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      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1323-2023 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.",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1323-2023&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-1323-2023&lang=eng"
        }
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      "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-1323-2023/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",
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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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          "item": {
            "Field": "Lot/code info",
            "Value": "a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101, GTIN 00613994960900, Serial Numbers:  A43107, A44312, A44898, A45026, A47094, A48070, A48239, A48726, A54374;  b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102, GTIN 00613994960894, Serial Numbers:  A39801, A40711, A42973, A43546, A44572, A44970, A45136, A45543, A46181, A46352, A46538, A46924, A47103, A47710, A48122, A48391, A50563, A50858, A51802, A52414, A53427, A54070, A54689, A54892;  c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103, GTIN 00613994960887, Serial Numbers:  A39091, A40452, A41163, A41376, A42289, A43008, A43345, A43555, A45523, A45714, A45746, A46289, A47357, A48134, A48230, A50024, A50343, A51014, A53131, A53706, A54060;  d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105, GTIN 00613994961136, Serial Numbers:  A39669, A41187, A41545, A42539, A42923, A43450, A43481, A43500, A43516, A43853, A43932, A43934, A44475, A44665, A44733, A44805, A44986, A45039, A45175, A45282, A45457, A45552, A45556, A45919, A47043, A47390, A47714, A47833, A47885, A48125, A48540, A48816, A49460, A49472, A50596, A51281, A53513, A53897, A54184, A54492, A54615, A54771, A54892, A54982;  e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110, GTIN 00613994961129, Serial Numbers:  A41514, A41616, A42444, A43082, A43201, A43235, A43608, A43805, A43852, A43925, A43955, A44054, A44267, A45150, A45454, A45474, A45680, A46359, A46622, A47260, A47287, A47525, A48070, A48080, A48092, A48565, A49050, A49411, A49520, A49924, A52108, A52214, A52379, A53417, A53518, A54052, A54164, A54172, A54245, A54678, A54994;   f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101, GTIN 00643169123106, Serial Numbers:  A38151-037, A38151-038, A38151-039, A38151-040, A38151-041, A38151-042, A38151-043, A38151-045, A38151-049, A38151-050, A38151-051, A38151-052, A38151-053, A38151-054, A38151-055, A38151-056, A38151-057, A38151-058, A38151-059, A38151-060, A38151-061, A38151-062, A38151-063, A38151-064, A38151-065, A38151-066, A38151-067, A38151-068, A38151-069, 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            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}