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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0670-2024.jsonld",
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  "name": "CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis  (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040",
  "description": "FDA recall Z-0670-2024 — Townsend Design is recalling CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis  (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040 (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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0670-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis  (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040",
    "manufacturer": {
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      "name": "Townsend Design"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0670-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0670-2024: Townsend Design is recalling CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis  (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040",
      "text": "The FDA logged enforcement record Z-0670-2024: Townsend Design is voluntarily recalling CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis  (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040 — reason: Due to potential air pockets between layers of material, their is the potential for complete struct breakage of  knee-ankle-foot orthosis.. Status: Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).. Initiated 2023-09-23. Affected lots/codes: REF: 17C1000: UDI: (01)04035459406987/Order #s: 875138 873876 870246 878309 870876 867906 867207 874519 870238 872326 880231 877998 881515 876713 873527 865318 872900 879715 871401 876266 869208 878409 872012 881081 876737 873872 873873 873874 881432 879731 869605 870645 872295 877649 880838 871165 881042 867389 872007 879027 872785 876112 876597 869483 876193 881451 872018 869463 879627 874007 877229 873391 871394 872322 879239 880900 878438 878984 869479 866311;  REF:17C2000: UDI: (01)04035459406970/Order #s: 877272 873876 878309 870876 878859 870238 872332 881515 865113 871377 873527 865318 872900 876830 879719 876266 869208 878409 879736 877464 881087 876758 882039 881432 868575 869605 870239 880069 881858 881004 871167 877863 879027 872785 876112 872231 867679 867192 869483 874204 871980 872018 869463 876197 874007 877229 877657 877032 877686 878973 871394 878061 877487 873224 879239 878438 878984 881309 869479 869481 867818 881671;  REF: 17C1010: UDI: (01)04035459407021/Order #s: 870369 881820 874040 879520 876180 870245 876186 871950 867672 878203 879246 880392 867984 879241 869603 877984 868694 876481 872772 869860 872009 869189 877643 874640 880427 867373 872516 869542 877296 870860 877502 867305 879052 878973 881513 865708 873091 879253;  REF:17C2010: UDI: (01)04035459407014/Order #s: 868833 881820 877376 874040 879520 876180 869636 876186 869607 867672 878203 879246 880212 867984 869391 878893 875114 881605 868694 874706 869860 877648 874640 867373 867171 872516 877296 870860 877502 867305 879052 873091 879253 874211;  REF:17C1040: UDI: (01)04035459407007/Order #s: 871643 871906 878303 869612 872321 872024 874230 876323 880348 878814 878816 871550 875852 880935 879597 880879 881558 875414 879602 880582 869590 869377 869013 872941 871638 870777;  REF:17C2040:UDI: (01)04035459406994/Order #s: 871407 878303 874794 872024 877715 867407 868726 880348 878814 878816 873386 877977 870640 878844 875126 880315 871164 881558 878181 870868 869377 869389 869013 870919 870777 868615 871970 875970;. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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        "occurred": true,
        "supported": true,
        "adjudged": true,
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      "grounding": {
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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-0670-2024&lang=eng",
        "value": "Devices recall, status Completed",
        "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-0670-2024&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-0670-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0670-2024 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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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class II",
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          "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-0670-2024&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-0670-2024/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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
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        "adjudged": false,
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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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            "Field": "Classification",
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            "Value": "Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Townsend Design",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to potential air pockets between layers of material, their is the potential for complete struct breakage of  knee-ankle-foot orthosis.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2023-09-23",
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          "item": {
            "Field": "Lot/code info",
            "Value": "REF: 17C1000: UDI: (01)04035459406987/Order #s: 875138 873876 870246 878309 870876 867906 867207 874519 870238 872326 880231 877998 881515 876713 873527 865318 872900 879715 871401 876266 869208 878409 872012 881081 876737 873872 873873 873874 881432 879731 869605 870645 872295 877649 880838 871165 881042 867389 872007 879027 872785 876112 876597 869483 876193 881451 872018 869463 879627 874007 877229 873391 871394 872322 879239 880900 878438 878984 869479 866311;  REF:17C2000: UDI: (01)04035459406970/Order #s: 877272 873876 878309 870876 878859 870238 872332 881515 865113 871377 873527 865318 872900 876830 879719 876266 869208 878409 879736 877464 881087 876758 882039 881432 868575 869605 870239 880069 881858 881004 871167 877863 879027 872785 876112 872231 867679 867192 869483 874204 871980 872018 869463 876197 874007 877229 877657 877032 877686 878973 871394 878061 877487 873224 879239 878438 878984 881309 869479 869481 867818 881671;  REF: 17C1010: UDI: (01)04035459407021/Order #s: 870369 881820 874040 879520 876180 870245 876186 871950 867672 878203 879246 880392 867984 879241 869603 877984 868694 876481 872772 869860 872009 869189 877643 874640 880427 867373 872516 869542 877296 870860 877502 867305 879052 878973 881513 865708 873091 879253;  REF:17C2010: UDI: (01)04035459407014/Order #s: 868833 881820 877376 874040 879520 876180 869636 876186 869607 867672 878203 879246 880212 867984 869391 878893 875114 881605 868694 874706 869860 877648 874640 867373 867171 872516 877296 870860 877502 867305 879052 873091 879253 874211;  REF:17C1040: UDI: (01)04035459407007/Order #s: 871643 871906 878303 869612 872321 872024 874230 876323 880348 878814 878816 871550 875852 880935 879597 880879 881558 875414 879602 880582 869590 869377 869013 872941 871638 870777;  REF:17C2040:UDI: (01)04035459406994/Order #s: 871407 878303 874794 872024 877715 867407 868726 880348 878814 878816 873386 877977 870640 878844 875126 880315 871164 881558 878181 870868 869377 869389 869013 870919 870777 868615 871970 875970;",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US: AL\tAR\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tIA\tID\tIL\tIN\tKENT\tKS\tKY\tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tQC\tSC\tSD\tTN\tTX\tUT\tVA\tVT\tWA\tWI\tWV\tWY, Puerto Rico,  OUS: None OUS: Canada, New Zealand, Japan, Australia, Netherlands, United Kingdom",
            "Status": "recorded"
          }
        }
      ]
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}