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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2411-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Endo Model  SL Tibial Components\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t  16-2817/02\tTibial Component, Small, W: 60mm  16-2817/05\tTibial Component, Medium, W: 65mm  16-2817/07\tTibial Component, Large, W: 75mm  16-2817/32\tTibial Component Modular, Small, W: 60mm  16-2817/35\tTibial Component Modular, Medium, W: 65mm  16-2817/37\tTibial Component Modular, Large, W: 75mm",
  "description": "FDA recall Z-2411-2024 — Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Endo Model  SL Tibial Components\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t  16-2817/02\tTibial Component, Small, W: 60mm  16-2817/05\tTibial Component, Medium, W: 65mm  16-2817/07\tTibial Component, Large, W: 75mm  16-2817/32\tTibial Component Modular, Small, W: 60mm  16-2817/35\tTibial Component Modular, Medium, W: 65mm  16-2817/37\tTibial Component Modular, Large, W: 75mm (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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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-2411-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Endo Model  SL Tibial Components\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t  16-2817/02\tTibial Component, Small, W: 60mm  16-2817/05\tTibial Component, Medium, W: 65mm  16-2817/07\tTibial Component, Large, W: 75mm  16-2817/32\tTibial Component Modular, Small, W: 60mm  16-2817/35\tTibial Component Modular, Medium, W: 65mm  16-2817/37\tTibial Component Modular, Large, W: 75mm",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Waldemar Link GmbH & Co. KG (Mfg Site)"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2411-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2411-2024: Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Endo Model  SL Tibial Components\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t  16-2817/02\tTibial Component, Small, W: 60mm  16-2817/05\tTibial Component, Medium, W: 65mm  16-2817/07\tTibial Component, Large, W: 75mm  16-2817/32\tTibial Component Modular, Small, W: 60mm  16-2817/35\tTibial Component Modular, Medium, W: 65mm  16-2817/37\tTibial Component Modular, Large, W: 75mm",
      "text": "The FDA logged enforcement record Z-2411-2024: Waldemar Link GmbH & Co. KG (Mfg Site) is voluntarily recalling Endo Model  SL Tibial Components\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t  16-2817/02\tTibial Component, Small, W: 60mm  16-2817/05\tTibial Component, Medium, W: 65mm  16-2817/07\tTibial Component, Large, W: 75mm  16-2817/32\tTibial Component Modular, Small, W: 60mm  16-2817/35\tTibial Component Modular, Medium, W: 65mm  16-2817/37\tTibial Component Modular, Large, W: 75mm — reason: Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-22. Affected lots/codes: Product                        UDI-DI 16-2817/02            04026575359202; 16-2817/05            04026575359219; 16-2817/07            04026575359226; 16-2817/32            04026575370870; 16-2817/35            04026575370887; 16-2817/37            04026575370894.  All product lots manufactured since 01-Jun-2022.. 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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        "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-2411-2024&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-2411-2024&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-2411-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2411-2024 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.",
      "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)",
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        "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-2411-2024&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-2411-2024/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,
        "supported": true,
        "adjudged": false,
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      },
      "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."
    }
  ],
  "hasPart": [
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      "name": "FDA recall details — Z-2411-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2411-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Waldemar Link GmbH & Co. KG (Mfg Site)",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-05-22",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Product                        UDI-DI 16-2817/02            04026575359202; 16-2817/05            04026575359219; 16-2817/07            04026575359226; 16-2817/32            04026575370870; 16-2817/35            04026575370887; 16-2817/37            04026575370894.  All product lots manufactured since 01-Jun-2022.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Nationwide Foreign:  Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Israel Italy Kenya Lithuania Luxembourg Mexico Netherlands Norway Peru Poland Romania Saudi Arabia Slovakia Slovenia Spain Sweden Switzerland Thailand T¿rkiye Ukraine United Arab Emirates United Kingdom Uruguay Vietnam",
            "Status": "recorded"
          }
        }
      ]
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}