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  "name": "SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX",
  "description": "FDA recall Z-0672-2024 — Townsend Design is recalling SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX (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": "SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0672-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0672-2024: Townsend Design is recalling SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX",
      "text": "The FDA logged enforcement record Z-0672-2024: Townsend Design is voluntarily recalling SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX — 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: 17VKCUS:UDI: /Order #s: 868003 864980 877514 867899 875411 875411 868308 871161 865211 881621 872534 881616 865744 866309 876670 877270 864959 869294 868549 864957 864595 866551 866682 863308 875500 873400 865509 868828 875846 877677 869358 876200 873155 867381 878188 870222 870222 869927 873860 873860 865503 878668 878182 863772 866842 878791 865507 863707 872687 868289 873685 870922 870922 864367 865966 875463 871512 871512 870916 866919 879216 878252 879014 874428 867045 878412 863471 871544 874438 872200 870646 872512 865508 865508 876593 869370 865720 863470 876045 867371 865737 868736 873157 867694 875149 867457 875554 863353 867286 873781 873357 867357 873861 871137               REF: 17VKCUSX: UDI:/Order #s: 873093 877251 877251 864343 864343 876329 867359 867359 876421 867376 868295 863890 873575 868834 874561 874561 877602 877602 872207 872835 864342 867052 874879 878550 865056 865056 879221 877567 882074 871827 871827 865201 877909 877909 869372 869374 866576 867687 874242 876221 876221 874239 877527 868310 864590 872312 872312 874217 874217 875682 875682 875682 875682 865743 864949 864949 864960 872833 872535 872535 870881 870881 875053 875053 877459 866653 876099 870214 873791 873025 863340 866810 868042 868534 869716 871539 874028 877634 865745 876675 872003 873863 874082 875898 873401 878664 871403 872028 865207 870243 873579 874453 874453 867886 878116 867382 871008 878134 865464 865464 867932 872463 872463 876902 876902 868831 869045 867147 865504 872823 871992 875377 871991 877676 877676 867685 866669 864414 879749 874886 868285 877400 851811 872744 867952 874200 879006 863770 867434 868553 868553 872288 878683 870549 870549 880814 869364 869364 873639 866843 866843 874962 867157 874203 877228 869368 877671 865110 877397 876724 876724 868568 874257 879001 869360 874434 865199 869355 869357 872782 872782 876495 878215 867953 877996 877996 865741 873810 877262 877262 866658 869190 865352 866846 866846 877116 877116 869120 881824 872223 868495 868495 879817 877705 868571 864955 869325 872022 876058 876506 865502 867369 871309 877674 873159 865734 874271 873186 873186 877902 871616 875378 879484 871718 873403 877625 877625 868835 872314 866526 866598 867787 868609 872580 872926 873740 873740 874952 875239 875239 878620 878914 867143 878743 875178 873923 870027 877741 867148 870660 877200 865435 864078 879739 877273 878832 878832 873169 865102 874535. A RECORDED FDA enforcement action (occurred=true).",
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        "supported": true,
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      "grounding": {
        "groundingType": "SourceCitation",
        "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-0672-2024&lang=eng",
        "value": "Devices recall, status Completed",
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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-0672-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0672-2024 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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        "adjudged": 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)",
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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-0672-2024/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": {
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        "supported": true,
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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": "Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).",
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            "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.",
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            "Field": "Lot/code info",
            "Value": "REF: 17VKCUS:UDI: /Order #s: 868003 864980 877514 867899 875411 875411 868308 871161 865211 881621 872534 881616 865744 866309 876670 877270 864959 869294 868549 864957 864595 866551 866682 863308 875500 873400 865509 868828 875846 877677 869358 876200 873155 867381 878188 870222 870222 869927 873860 873860 865503 878668 878182 863772 866842 878791 865507 863707 872687 868289 873685 870922 870922 864367 865966 875463 871512 871512 870916 866919 879216 878252 879014 874428 867045 878412 863471 871544 874438 872200 870646 872512 865508 865508 876593 869370 865720 863470 876045 867371 865737 868736 873157 867694 875149 867457 875554 863353 867286 873781 873357 867357 873861 871137               REF: 17VKCUSX: UDI:/Order #s: 873093 877251 877251 864343 864343 876329 867359 867359 876421 867376 868295 863890 873575 868834 874561 874561 877602 877602 872207 872835 864342 867052 874879 878550 865056 865056 879221 877567 882074 871827 871827 865201 877909 877909 869372 869374 866576 867687 874242 876221 876221 874239 877527 868310 864590 872312 872312 874217 874217 875682 875682 875682 875682 865743 864949 864949 864960 872833 872535 872535 870881 870881 875053 875053 877459 866653 876099 870214 873791 873025 863340 866810 868042 868534 869716 871539 874028 877634 865745 876675 872003 873863 874082 875898 873401 878664 871403 872028 865207 870243 873579 874453 874453 867886 878116 867382 871008 878134 865464 865464 867932 872463 872463 876902 876902 868831 869045 867147 865504 872823 871992 875377 871991 877676 877676 867685 866669 864414 879749 874886 868285 877400 851811 872744 867952 874200 879006 863770 867434 868553 868553 872288 878683 870549 870549 880814 869364 869364 873639 866843 866843 874962 867157 874203 877228 869368 877671 865110 877397 876724 876724 868568 874257 879001 869360 874434 865199 869355 869357 872782 872782 876495 878215 867953 877996 877996 865741 873810 877262 877262 866658 869190 865352 866846 866846 877116 877116 869120 881824 872223 868495 868495 879817 877705 868571 864955 869325 872022 876058 876506 865502 867369 871309 877674 873159 865734 874271 873186 873186 877902 871616 875378 879484 871718 873403 877625 877625 868835 872314 866526 866598 867787 868609 872580 872926 873740 873740 874952 875239 875239 878620 878914 867143 878743 875178 873923 870027 877741 867148 870660 877200 865435 864078 879739 877273 878832 878832 873169 865102 874535",
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            "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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