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  "name": "Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix",
  "description": "FDA recall Z-0163-2024 — Medtronic Sofamor Danek USA Inc is recalling Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; 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": "FDA recall Z-0163-2024: Medtronic Sofamor Danek USA Inc is recalling Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix",
      "text": "The FDA logged enforcement record Z-0163-2024: Medtronic Sofamor Danek USA Inc is voluntarily recalling Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; 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) T42200:  GTIN 00643169123052, Serial Numbers:  A59254-013, A57871-018, A59117-013, A59254-018, A59264-016, A58526-014, A58526-015, A58526-016, A58864-018, A58082-016, A58983-011, A58983-012, A59320-013, A59320-016, A57043-011, A58831-018, A59307-012, A59320-019, A58831-019, A59117-020, A57104-018, A58408-015, A58408-016, A58952-019, A59307-011, A59264-014, A58526-011, A58526-012, A58408-011, A58995-025, A59140-014, A59140-015, A59165-012, A56808-011, A56808-012, A57078-011, A57078-012, A58077-013, A59117-021, A59264-015, A57871-014, A56808-019, A56808-020, A57078-013, A57078-014, A57078-015, A57078-016, A57078-017, A58649-011, A58649-012, A58649-013, A58649-014, A58649-015, A58649-016, A58649-017, A58983-018, A58983-019, A58983-020, A59117-011, A59117-015, A58983-017, A58995-026, A56808-013, A58408-012, A57104-011, A58077-014, A59165-013, A59165-014, A58864-012, A56808-016, A56808-017, A57043-019, A57104-012, A57104-013, A57104-014, A57104-015, A58701-011, A58701-012, A58701-013, A58701-014, A58701-015, A58701-016, A58864-011, A58952-011, A58952-012, A58864-013, A58864-014, A58864-015, A58526-017, A59243-014, A58831-011, A58077-015, A58077-016, A58077-017, A58605-011, A58526-013, A59254-017, A57871-015, A57871-016, A58082-011, A59165-020, A59264-017, A59264-018, A56808-014, A58831-012, A59243-013, A59243-016, A59243-017, A59254-014, A59254-016, A59320-014, A58605-012, A58605-013, A58605-014, A58605-015, A57043-015, A58983-013, A58649-018, A58864-016, A58864-017, A59140-013, A59140-017, A59140-019, A59140-020, A59254-015, A59320-020, A59320-021, A57043-012, A58831-013, A58831-014, A56808-015, A57104-016, A58983-014, A58983-015, A58983-016, A59117-014, A59117-016, A59117-017, A57871-013, A58082-012, A58952-015, A59140-018, A59264-013, A58831-015, A58831-016, A58831-017, A58859-011, A57043-016, A58831-020, A58859-012, A58859-013, A58859-014, A59264-019, A59264-020, A59320-011, A59320-012, A59243-015, A59307-013, A59320-017, A59320-018, A58082-015, A58859-015, A59307-014, A59307-015, A58082-019, A58082-020, A58952-020, A59254-011, A57043-013, A58408-014, A59117-018, A59117-019, A58841-015, A58841-016, A58841-017, A58841-018, A59165-015, A59165-016, A59165-017, A59165-018, A57043-017, A57043-018, A58082-013, A58408-013, A59140-011, A59140-012, A57043-014, A58952-013, A58952-014, A58077-011, A58082-014, A59165-019, A57871-011, A57871-012, A58082-017, A58082-018, A59264-011, A59264-012, A58077-012, A59165-011, A58859-016, A58859-017, A57104-017, A58859-018, A56808-018, A57871-017, A58408-017, A59140-016, A58841-014, A58952-016, A59117-012, A59243-018, A59320-015, A59254-012;   b) T42210:  GTIN 00643169123069, Serial Numbers:  A58133-043, A59122-023, A58133-046, A58518-019, A58518-020, A57362-017, A57362-019, A58545-022, A58133-045, A57362-011, A58545-028, A59122-022, A57344-020, A59122-017, A57344-021, A58133-044, A59122-018, A57344-022, A57344-018, A57344-019, A58545-024, A58518-015, A58545-011, A58545-012, A58133-047, A58518-011, A58518-012, A58518-013, A58518-014, A58122-011, A58122-012, A58122-013, A58122-014, A58122-015, A58122-016, A58122-017, A58122-018, A57344-023, A58518-016, A57387-026, A57387-027, A58518-017, A58518-018, A58545-013, A58545-014, A57387-029, A58518-031, A57344-024, A57387-011, A57387-012, A57387-013, A57387-014, A57387-015, A59122-019, A59122-020, A59122-021, A59122-024, A58518-021, A58518-022, A58518-023, A58518-024, A58518-025, A59200-013, A57362-012, A57362-013, A59200-014, A59200-015, A58545-016, A58545-023, A57387-024, A58545-015, A59122-025, A59122-026, A59122-027, A59200-011, A59200-012, A57344-013, A57344-025, A58545-017, A58545-018, A57344-017, A58133-041, A58133-042, A57387-016, A57387-017, A59200-016, A59200-017, A59200-018, A59200-019, A59200-020, A59200-021, A59200-022, A57387-028, A58133-036, A58133-040, A58545-029, A57362-014, A57362-015, A57362-016, A57387-018, A57387-019, A57387-020, A57387-021, A57387-022, A57387-023, A58122-019, A58122-020, A58122-021, A58122-022, A58122-023, A58133-039, A57362-018, A58518-032, A58518-033, A58518-034, A58133-031, A58518-028, A59200-023, A59200-024, A57362-020, A57362-021, A57362-022, A58122-024, A58122-025, A58518-026, A58545-021, A59200-025, A59200-026, A58545-019, A58545-020, A58133-032, A58133-033, A58133-035, A58518-027, A59200-027, A58133-034, A59122-014, A57344-011, A57344-012, A57344-014, A57344-015, A57344-016, A59200-028, A58545-025, A58545-026, A58545-027, A58518-030, A58133-037, A58133-038, A58518-029, A59122-015, A59122-016, A57387-025, A57362-023, A57362-024, A57362-025, A58122-026, A58122-027, A58122-028, A58122-029, A59122-011, A59122-012, A59122-013. A RECORDED FDA enforcement action (occurred=true).",
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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-0163-2024/fda-classification",
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      "name": "FDA classified recall Z-0163-2024 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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        "value": "Class II",
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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."
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      "@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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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
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      "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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            "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.",
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            "Field": "Initiated",
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            "Value": "a) T42200:  GTIN 00643169123052, Serial Numbers:  A59254-013, A57871-018, A59117-013, A59254-018, A59264-016, A58526-014, A58526-015, A58526-016, A58864-018, A58082-016, A58983-011, A58983-012, A59320-013, A59320-016, A57043-011, A58831-018, A59307-012, A59320-019, A58831-019, A59117-020, A57104-018, A58408-015, A58408-016, A58952-019, A59307-011, A59264-014, A58526-011, A58526-012, A58408-011, A58995-025, A59140-014, A59140-015, A59165-012, A56808-011, A56808-012, A57078-011, A57078-012, A58077-013, A59117-021, A59264-015, A57871-014, A56808-019, A56808-020, A57078-013, A57078-014, A57078-015, A57078-016, A57078-017, A58649-011, A58649-012, A58649-013, A58649-014, A58649-015, A58649-016, A58649-017, A58983-018, A58983-019, A58983-020, A59117-011, A59117-015, A58983-017, A58995-026, A56808-013, A58408-012, A57104-011, A58077-014, A59165-013, A59165-014, A58864-012, A56808-016, A56808-017, A57043-019, A57104-012, A57104-013, A57104-014, A57104-015, A58701-011, A58701-012, A58701-013, A58701-014, A58701-015, A58701-016, A58864-011, A58952-011, A58952-012, A58864-013, A58864-014, A58864-015, A58526-017, A59243-014, A58831-011, A58077-015, A58077-016, A58077-017, A58605-011, A58526-013, A59254-017, A57871-015, A57871-016, A58082-011, A59165-020, A59264-017, A59264-018, A56808-014, A58831-012, A59243-013, A59243-016, A59243-017, A59254-014, A59254-016, A59320-014, A58605-012, A58605-013, A58605-014, A58605-015, A57043-015, A58983-013, A58649-018, A58864-016, A58864-017, A59140-013, A59140-017, A59140-019, A59140-020, A59254-015, A59320-020, A59320-021, A57043-012, A58831-013, A58831-014, A56808-015, A57104-016, A58983-014, A58983-015, A58983-016, A59117-014, A59117-016, A59117-017, A57871-013, A58082-012, A58952-015, A59140-018, A59264-013, A58831-015, A58831-016, A58831-017, A58859-011, A57043-016, A58831-020, A58859-012, A58859-013, A58859-014, A59264-019, A59264-020, A59320-011, A59320-012, A59243-015, A59307-013, A59320-017, A59320-018, A58082-015, A58859-015, A59307-014, A59307-015, A58082-019, A58082-020, A58952-020, A59254-011, A57043-013, A58408-014, A59117-018, A59117-019, A58841-015, A58841-016, A58841-017, A58841-018, A59165-015, A59165-016, A59165-017, A59165-018, A57043-017, A57043-018, A58082-013, A58408-013, A59140-011, A59140-012, A57043-014, A58952-013, A58952-014, A58077-011, A58082-014, A59165-019, A57871-011, A57871-012, A58082-017, A58082-018, A59264-011, A59264-012, A58077-012, A59165-011, A58859-016, A58859-017, A57104-017, A58859-018, A56808-018, A57871-017, A58408-017, A59140-016, A58841-014, A58952-016, A59117-012, A59243-018, A59320-015, A59254-012;   b) T42210:  GTIN 00643169123069, Serial Numbers:  A58133-043, A59122-023, A58133-046, A58518-019, A58518-020, A57362-017, A57362-019, A58545-022, A58133-045, A57362-011, A58545-028, A59122-022, A57344-020, A59122-017, A57344-021, A58133-044, A59122-018, A57344-022, A57344-018, A57344-019, A58545-024, A58518-015, A58545-011, A58545-012, A58133-047, A58518-011, A58518-012, A58518-013, A58518-014, A58122-011, A58122-012, A58122-013, A58122-014, A58122-015, A58122-016, A58122-017, A58122-018, A57344-023, A58518-016, A57387-026, A57387-027, A58518-017, A58518-018, A58545-013, A58545-014, A57387-029, A58518-031, A57344-024, A57387-011, A57387-012, A57387-013, A57387-014, A57387-015, A59122-019, A59122-020, A59122-021, A59122-024, A58518-021, A58518-022, A58518-023, A58518-024, A58518-025, A59200-013, A57362-012, A57362-013, A59200-014, A59200-015, A58545-016, A58545-023, A57387-024, A58545-015, A59122-025, A59122-026, A59122-027, A59200-011, A59200-012, A57344-013, A57344-025, A58545-017, A58545-018, A57344-017, A58133-041, A58133-042, A57387-016, A57387-017, A59200-016, A59200-017, A59200-018, A59200-019, A59200-020, A59200-021, A59200-022, A57387-028, A58133-036, A58133-040, A58545-029, A57362-014, A57362-015, A57362-016, A57387-018, A57387-019, A57387-020, A57387-021, A57387-022, A57387-023, A58122-019, A58122-020, A58122-021, A58122-022, A58122-023, A58133-039, A57362-018, A58518-032, A58518-033, A58518-034, A58133-031, A58518-028, A59200-023, A59200-024, A57362-020, A57362-021, A57362-022, A58122-024, A58122-025, A58518-026, A58545-021, A59200-025, A59200-026, A58545-019, A58545-020, A58133-032, A58133-033, A58133-035, A58518-027, A59200-027, A58133-034, A59122-014, A57344-011, A57344-012, A57344-014, A57344-015, A57344-016, A59200-028, A58545-025, A58545-026, A58545-027, A58518-030, A58133-037, A58133-038, A58518-029, A59122-015, A59122-016, A57387-025, A57362-023, A57362-024, A57362-025, A58122-026, A58122-027, A58122-028, A58122-029, A59122-011, A59122-012, A59122-013",
            "Status": "recorded"
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            "Field": "Distribution pattern",
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}