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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1881-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M.    Component of ELEOS LIMB SALVAGE SYSTEM",
  "description": "FDA recall Z-1881-2025 — Onkos Surgical, Inc. is recalling Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M.    Component of ELEOS LIMB SALVAGE SYSTEM (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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1881-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M.    Component of ELEOS LIMB SALVAGE SYSTEM",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Onkos Surgical, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1881-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1881-2025: Onkos Surgical, Inc. is recalling Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M.    Component of ELEOS LIMB SALVAGE SYSTEM",
      "text": "The FDA logged enforcement record Z-1881-2025: Onkos Surgical, Inc. is voluntarily recalling Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M.    Component of ELEOS LIMB SALVAGE SYSTEM — reason: Potential for breach of Tyvek seals.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-01. Affected lots/codes: a. Model Number: FS-11120-03M; UDI-DI: B278FS1112003M0; Lot Numbers: 1880532, 1880533, 1880534, 1880535, 1880536, 1880537, 1880538, 1880539, 1880540, 1880541, 1880542, 1880543.  b. Model Number: FS-12120-03M; UDI-DI: B278FS1212003M0; Lot Numbers: 1880544, 1880545, 1880546, 1880547, 1880548, 1880549, 1880550, 1880551, 1880552, 1880553.  c. Model Number: FS-13120-03M; UDI-DI: B278FS1312003M0; Lot Numbers: 1880554, 1880555, 1880556, 1880557, 1880558, 1880559, 1880560, 1880561, 1880562, 1880563.  d. Model Number: FS-14120-03M; UDI-DI: B278FS1412003M0; Lot Numbers: 1880564, 1880565, 1880566, 1880567, 1880568, 1880569, 1880570, 1880571, 1880572, 1880573, 1880574.  e. Model Number: FS-15120-03M; UDI-DI: B278FS1512003M0; Lot Numbers: 1880575, 1880576, 1880577, 1880578, 1880579, 1880580, 1880581, 1880582, 1880583, 1880584, 1880585, 1880586, 1880587.  f. Model Number: FS-16120-03M; UDI-DI: B278FS1612003M0; Lot Numbers: 1880588, 1880589, 1880590, 1880591, 1880592, 1880593, 1880594, 1880595, 1880596, 1880597, 1880598.  g. Model Number: FS-17120-03M; UDI-DI: B278FS1712003M0; Lot Numbers: 1880599, 1880600, 1880601, 1880602, 1880603, 1880604, 1880605, 1880606, 1880607, 1880608, 1880609, 1880610, 1880611.  h. Model Number: FS-18120-03M; UDI-DI: B278FS1812003M0; Lot Numbers: 1880612, 1880613, 1880614, 1880615, 1880616, 1880617, 1880618, 1880619, 1880620, 1880621, 1880622, 1880623.  i. Model Number: FS-19120-03M; UDI-DI: B278FS1912003M0; Lot Numbers: 1880624, 1880625, 1880626, 1880627, 1880628, 1880629, 1880630, 1880631, 1880632.  j. Model Number: FS-20120-03M; UDI-DI: B278FS2012003M0; Lot Numbers: 1880633, 1880634, 1880635, 1880636, 1880637, 1880638, 1880639.  k. Model Number: FS-21120-03M; UDI-DI: B278FS2112003M0; Lot Numbers: 1880640, 1880641, 1880642, 1880643, 1880644, 1880645, 1880646, 1880647, 1880648, 1880649, 1880650, 1880651.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": 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-1881-2025&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-1881-2025&lang=eng"
        }
      },
      "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-1881-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1881-2025 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1881-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "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-1881-2025&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-1881-2025/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,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "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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      "name": "FDA recall details — Z-1881-2025",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1881-2025",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
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          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Onkos Surgical, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential for breach of Tyvek seals.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-09-01",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a. Model Number: FS-11120-03M; UDI-DI: B278FS1112003M0; Lot Numbers: 1880532, 1880533, 1880534, 1880535, 1880536, 1880537, 1880538, 1880539, 1880540, 1880541, 1880542, 1880543.  b. Model Number: FS-12120-03M; UDI-DI: B278FS1212003M0; Lot Numbers: 1880544, 1880545, 1880546, 1880547, 1880548, 1880549, 1880550, 1880551, 1880552, 1880553.  c. Model Number: FS-13120-03M; UDI-DI: B278FS1312003M0; Lot Numbers: 1880554, 1880555, 1880556, 1880557, 1880558, 1880559, 1880560, 1880561, 1880562, 1880563.  d. Model Number: FS-14120-03M; UDI-DI: B278FS1412003M0; Lot Numbers: 1880564, 1880565, 1880566, 1880567, 1880568, 1880569, 1880570, 1880571, 1880572, 1880573, 1880574.  e. Model Number: FS-15120-03M; UDI-DI: B278FS1512003M0; Lot Numbers: 1880575, 1880576, 1880577, 1880578, 1880579, 1880580, 1880581, 1880582, 1880583, 1880584, 1880585, 1880586, 1880587.  f. Model Number: FS-16120-03M; UDI-DI: B278FS1612003M0; Lot Numbers: 1880588, 1880589, 1880590, 1880591, 1880592, 1880593, 1880594, 1880595, 1880596, 1880597, 1880598.  g. Model Number: FS-17120-03M; UDI-DI: B278FS1712003M0; Lot Numbers: 1880599, 1880600, 1880601, 1880602, 1880603, 1880604, 1880605, 1880606, 1880607, 1880608, 1880609, 1880610, 1880611.  h. Model Number: FS-18120-03M; UDI-DI: B278FS1812003M0; Lot Numbers: 1880612, 1880613, 1880614, 1880615, 1880616, 1880617, 1880618, 1880619, 1880620, 1880621, 1880622, 1880623.  i. Model Number: FS-19120-03M; UDI-DI: B278FS1912003M0; Lot Numbers: 1880624, 1880625, 1880626, 1880627, 1880628, 1880629, 1880630, 1880631, 1880632.  j. Model Number: FS-20120-03M; UDI-DI: B278FS2012003M0; Lot Numbers: 1880633, 1880634, 1880635, 1880636, 1880637, 1880638, 1880639.  k. Model Number: FS-21120-03M; UDI-DI: B278FS2112003M0; Lot Numbers: 1880640, 1880641, 1880642, 1880643, 1880644, 1880645, 1880646, 1880647, 1880648, 1880649, 1880650, 1880651.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}