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  "name": "Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix",
  "description": "FDA recall Z-0164-2024 — Medtronic Sofamor Danek USA Inc is recalling Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; 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 DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0164-2024/enforcement-record",
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      "name": "FDA recall Z-0164-2024: Medtronic Sofamor Danek USA Inc is recalling Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix",
      "text": "The FDA logged enforcement record Z-0164-2024: Medtronic Sofamor Danek USA Inc is voluntarily recalling Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; 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) T42275:  GTIN 00643169123076, Serial Numbers:  A58988-042, A58156-043, A59160-040, A59343-027, A58156-049, A58988-029, A58821-051, A58156-050, A59343-029, A59343-030, A59343-031, A59343-032, A59343-033, A59269-016, A59154-026, A59343-043, A59160-046, A59154-038, A59154-039, A59154-040, A59154-041, A59154-042, A58821-048, A58821-049, A59343-020, A59343-021, A59343-024, A59343-025, A59343-026, A58821-056, A58821-057, A58988-040, A59154-031, A59160-044, A58988-018, A58821-026, A58821-027, A58821-028, A58821-029, A58821-030, A58988-019, A58988-020, A58988-021, A59119-027, A58156-042, A58821-053, A58821-054, A58821-055, A58988-043, A58988-044, A58988-045, A59119-011, A59119-012, A59119-013, A59119-014, A59119-015, A59119-016, A59119-017, A59119-032, A59119-033, A59119-034, A59154-014, A59154-015, A59154-016, A59160-018, A59160-019, A59343-011, A59343-012, A59343-013, A59160-035, A59160-036, A59160-037, A58821-021, A58821-022, A58988-022, A58988-023, A58821-031, A58821-032, A58988-024, A59343-014, A59343-015, A58821-024, A58821-025, A59119-030, A59119-031, A58988-025, A58988-026, A58988-027, A58988-028, A59160-016, A59160-029, A59160-030, A59160-031, A59160-032, A59343-016, A59343-017, A59343-018, A58821-033, A59119-018, A59154-043, A59154-044, A59160-033, A59160-042, A59160-043, A58988-030, A58821-050, A59119-019, A59119-020, A59119-021, A59119-022, A59119-023, A59119-024, A59119-025, A59154-025, A59160-041, A59160-048, A59160-049, A58821-052, A58988-041, A59154-018, A59154-024, A59160-020, A59343-028, A58988-011, A58988-012, A59160-012, A59160-013, A59160-015, A58156-032, A58156-035, A58821-034, A58821-035, A58821-036, A59154-017, A59160-024, A59160-034, A59269-018, A58821-037, A58821-038, A58988-031, A58988-032, A58988-033, A58988-034, A58821-039, A58821-040, A59154-030, A58156-051, A59119-028, A59119-029, A59160-047, A59269-017, A58821-041, A58821-023, A58988-013, A58988-014, A58988-015, A59119-026, A59154-034, A59154-045, A59154-046, A59160-011, A59343-019, A58988-035, A59160-017, A58821-042, A58988-037, A59343-034, A58156-052, A59154-033, A59269-012, A59269-013, A59269-014, A59269-015, A58156-045, A58156-046, A58156-047, A58156-048, A59343-035, A59160-025, A59269-011, A59343-036, A59343-037, A58988-036, A59160-023, A59160-026, A59154-036, A59154-037, A59160-039, A59343-022, A59343-023, A58821-043, A58821-044, A58821-045, A58821-046, A58821-047, A58988-038, A58988-039, A59154-047, A59154-048, A59160-021, A59160-022, A59160-027, A59160-028, A59160-038, A59160-045, A59343-038, A59343-039, A59343-040, A59343-041, A59343-042, A58988-016, A58988-017;   b) T42280, GTIN 00643169123083, Serial Numbers:  A58840-084, A58489-021, A57660-021, A58489-023, A58489-024, A58812-035, A58812-038, A58582-011, A58264-023, A58264-024, A58264-025, A58264-011, A58264-012, A58489-017, A58489-018, A58840-087, A58489-011, A58085-011, A58840-091, A58812-031, A58840-088, A58840-086, A58812-041, A58812-042, A58812-032, A58812-033, A58812-034, A58840-080, A57660-011, A57660-012, A57660-013, A57660-014, A57660-017, A57660-018, A58264-013, A58812-045, A58840-076, A58840-077, A58840-078, A57660-019, A57660-020, A58840-082, A58489-022, A57660-015, A57660-016, A58812-039, A58840-079, A58840-085, A58264-014, A58489-020, A58812-037, A58812-043, A58812-044, A58840-081, A58840-083, A58812-040, A58489-019, A58812-036, A58840-089, A58264-015, A58264-016, A58264-017, A58264-018, A58264-019, A58264-020, A58489-012, A58489-013, A58489-014, A58264-021, A58264-022. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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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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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0164-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0164-2024 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.",
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      "reviewStatus": "current",
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      "epistemicStatus": {
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        "supported": true,
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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-0164-2024/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)",
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        "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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            "Value": "Z-0164-2024",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "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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          "item": {
            "Field": "Lot/code info",
            "Value": "a) T42275:  GTIN 00643169123076, Serial Numbers:  A58988-042, A58156-043, A59160-040, A59343-027, A58156-049, A58988-029, A58821-051, A58156-050, A59343-029, A59343-030, A59343-031, A59343-032, A59343-033, A59269-016, A59154-026, A59343-043, A59160-046, A59154-038, A59154-039, A59154-040, A59154-041, A59154-042, A58821-048, A58821-049, A59343-020, A59343-021, A59343-024, A59343-025, A59343-026, A58821-056, A58821-057, A58988-040, A59154-031, A59160-044, A58988-018, A58821-026, A58821-027, A58821-028, A58821-029, A58821-030, A58988-019, A58988-020, A58988-021, A59119-027, A58156-042, A58821-053, A58821-054, A58821-055, A58988-043, A58988-044, A58988-045, A59119-011, A59119-012, A59119-013, A59119-014, A59119-015, A59119-016, A59119-017, A59119-032, A59119-033, A59119-034, A59154-014, A59154-015, A59154-016, A59160-018, A59160-019, A59343-011, A59343-012, A59343-013, A59160-035, A59160-036, A59160-037, A58821-021, A58821-022, A58988-022, A58988-023, A58821-031, A58821-032, A58988-024, A59343-014, A59343-015, A58821-024, A58821-025, A59119-030, A59119-031, A58988-025, A58988-026, A58988-027, A58988-028, A59160-016, A59160-029, A59160-030, A59160-031, A59160-032, A59343-016, A59343-017, A59343-018, A58821-033, A59119-018, A59154-043, A59154-044, A59160-033, A59160-042, A59160-043, A58988-030, A58821-050, A59119-019, A59119-020, A59119-021, A59119-022, A59119-023, A59119-024, A59119-025, A59154-025, A59160-041, A59160-048, A59160-049, A58821-052, A58988-041, A59154-018, A59154-024, A59160-020, A59343-028, A58988-011, A58988-012, A59160-012, A59160-013, A59160-015, A58156-032, A58156-035, A58821-034, A58821-035, A58821-036, A59154-017, A59160-024, A59160-034, A59269-018, A58821-037, A58821-038, A58988-031, A58988-032, A58988-033, A58988-034, A58821-039, A58821-040, A59154-030, A58156-051, A59119-028, A59119-029, A59160-047, A59269-017, A58821-041, A58821-023, A58988-013, A58988-014, A58988-015, A59119-026, A59154-034, A59154-045, A59154-046, A59160-011, A59343-019, A58988-035, A59160-017, A58821-042, A58988-037, A59343-034, A58156-052, A59154-033, A59269-012, A59269-013, A59269-014, A59269-015, A58156-045, A58156-046, A58156-047, A58156-048, A59343-035, A59160-025, A59269-011, A59343-036, A59343-037, A58988-036, A59160-023, A59160-026, A59154-036, A59154-037, A59160-039, A59343-022, A59343-023, A58821-043, A58821-044, A58821-045, A58821-046, A58821-047, A58988-038, A58988-039, A59154-047, A59154-048, A59160-021, A59160-022, A59160-027, A59160-028, A59160-038, A59160-045, A59343-038, A59343-039, A59343-040, A59343-041, A59343-042, A58988-016, A58988-017;   b) T42280, GTIN 00643169123083, Serial Numbers:  A58840-084, A58489-021, A57660-021, A58489-023, A58489-024, A58812-035, A58812-038, A58582-011, A58264-023, A58264-024, A58264-025, A58264-011, A58264-012, A58489-017, A58489-018, A58840-087, A58489-011, A58085-011, A58840-091, A58812-031, A58840-088, A58840-086, A58812-041, A58812-042, A58812-032, A58812-033, A58812-034, A58840-080, A57660-011, A57660-012, A57660-013, A57660-014, A57660-017, A57660-018, A58264-013, A58812-045, A58840-076, A58840-077, A58840-078, A57660-019, A57660-020, A58840-082, A58489-022, A57660-015, A57660-016, A58812-039, A58840-079, A58840-085, A58264-014, A58489-020, A58812-037, A58812-043, A58812-044, A58840-081, A58840-083, A58812-040, A58489-019, A58812-036, A58840-089, A58264-015, A58264-016, A58264-017, A58264-018, A58264-019, A58264-020, A58489-012, A58489-013, A58489-014, A58264-021, A58264-022",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US, Colombia, S. Korea, New Zealand, India, Taiwan",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}