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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1102-2023.jsonld",
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  "name": "WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device    Type         Part Number  XXS           10-702-080095-0  XS              10-702-095115-0  Short        10-702-115150-0  Medium    10-702-140200  Long          10-702-190300-0",
  "description": "FDA recall Z-1102-2023 — Wishbone Medical, Inc. is recalling WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device    Type         Part Number  XXS           10-702-080095-0  XS              10-702-095115-0  Short        10-702-115150-0  Medium    10-702-140200  Long          10-702-190300-0 (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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    "name": "WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device    Type         Part Number  XXS           10-702-080095-0  XS              10-702-095115-0  Short        10-702-115150-0  Medium    10-702-140200  Long          10-702-190300-0",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Wishbone Medical, Inc."
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  "claims": [
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1102-2023/enforcement-record",
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      "name": "FDA recall Z-1102-2023: Wishbone Medical, Inc. is recalling WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device    Type         Part Number  XXS           10-702-080095-0  XS              10-702-095115-0  Short        10-702-115150-0  Medium    10-702-140200  Long          10-702-190300-0",
      "text": "The FDA logged enforcement record Z-1102-2023: Wishbone Medical, Inc. is voluntarily recalling WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device    Type         Part Number  XXS           10-702-080095-0  XS              10-702-095115-0  Short        10-702-115150-0  Medium    10-702-140200  Long          10-702-190300-0 — reason: Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-01-04. Affected lots/codes: XXS, Part No. 10-702-080095-0 UDI-DI B5621070208009500 Lot 1048176, 1048221  XS, Part No. 10-702-095115-0 UDI-DI B5621070209511500 Lot 1048177  Short, Part No. 10-702-115150-0 UDI-DI B5621070211515000 Lot 1048178, 1048222, 1048223  Medium, Part No. 10-702-140200 UDI-DI B562107021402000 Lot 1048179  Long, Part No.  10-702-190300-0 UDI-DI B5621070219030000 Lot 1048180. A RECORDED FDA enforcement action (occurred=true).",
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      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": 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-1102-2023&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-1102-2023&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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      "name": "FDA classified recall Z-1102-2023 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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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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        }
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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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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1102-2023/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.",
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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": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Wishbone Medical, Inc.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.",
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            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the state of South Carolina.",
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