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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2156-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "OPTETRAK One Peg Patella,, Item Numbers:    a)\t200-03-26, 26MM;   b)\t200-03-29, 29MM;   c)\t200-03-32, 32MM;   d)\t200-03-35, 35MM;   e)\t200-03-38, 38MM;   f)\t200-03-41, 41MM",
  "description": "FDA recall Z-2156-2024 — Exactech, Inc. is recalling OPTETRAK One Peg Patella,, Item Numbers:    a)\t200-03-26, 26MM;   b)\t200-03-29, 29MM;   c)\t200-03-32, 32MM;   d)\t200-03-35, 35MM;   e)\t200-03-38, 38MM;   f)\t200-03-41, 41MM (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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  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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-2156-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "OPTETRAK One Peg Patella,, Item Numbers:    a)\t200-03-26, 26MM;   b)\t200-03-29, 29MM;   c)\t200-03-32, 32MM;   d)\t200-03-35, 35MM;   e)\t200-03-38, 38MM;   f)\t200-03-41, 41MM",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Exactech, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2156-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2156-2024: Exactech, Inc. is recalling OPTETRAK One Peg Patella,, Item Numbers:    a)\t200-03-26, 26MM;   b)\t200-03-29, 29MM;   c)\t200-03-32, 32MM;   d)\t200-03-35, 35MM;   e)\t200-03-38, 38MM;   f)\t200-03-41, 41MM",
      "text": "The FDA logged enforcement record Z-2156-2024: Exactech, Inc. is voluntarily recalling OPTETRAK One Peg Patella,, Item Numbers:    a)\t200-03-26, 26MM;   b)\t200-03-29, 29MM;   c)\t200-03-32, 32MM;   d)\t200-03-35, 35MM;   e)\t200-03-38, 38MM;   f)\t200-03-41, 41MM — reason: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-18. Affected lots/codes: a) 200-03-26, UDI/DI 10885862039637, Lot Numbers:  6389536, 6389549, 6389551, 6389538, 6389540, 6389531, 6389537, 6389529, 6389534, 6389542, 6389545, 6711546, 6711550, 6389547, 6389548, 6389555, 6711540;   b) 200-03-29, UDI/DI 10885862039644, Lot Numbers:  6276447, 6276452, 6385318, 6385319, 6607740, 6385323, 6385304, 6385321, 6276446, 6276448, 6385300, 6276442, 6385310, 6385316, 6385325, 6607741, 7037109, 6276425, 6276429, 6276428, 6276433, 6276450, 6276453, 6607760, 6276437, 6276440, 6607751, 6607754, 6276426, 6276445, 6276449, 6607744, 6607759, 6276434, 6276435, 6276443, 6276451, 6385307;   c) 200-03-32, UDI/DI 10885862039651, Lot Numbers:  6385285, 6385286, 6844803, 6844831, 6385268, 6385278, 7043349, 7043358, 7043331, 6844822, 6385266, 6385269, 6385272, 6385277, 6385274, 7043330, 7043333, 7043336, 7043337, 7043342, 7043343, 7043356, 6385273, 6385281, 6385294, 6844804, 6844817, 6844818, 6844826;   d) 200-03-35, UDI/DI 10885862039668, Lot Numbers:  6711235, 6711254, 7044342, 7044351, 7044345, 6711236, 6711253, 7044338, 7044347, 7044349, 7044348, 6711245, 7044352, 7044336, 7044350;   e) 200-03-38, UDI/DI 10885862039675, Lot Numbers:  6401867, 6401876, 6401870, 7043457, 6401882, 6401868, 6401871, 7043466, 7043474, 6401858, 6401872, 7043460, 6923186, 6401873, 6923184, 6401855, 6401860, 6401877, 6401879, 7043459, 7043463;   f) 200-03-41, UDI/DI 10885862039682, Lot Numbers:  6389208, 6389211, 6389221, 6389216, 6389215, 6389220, 6389225, 6389213, 6389223, 6389224, 6389217, 6389226, 6389210, 6389222, 6389214, 6389207, 6389212, 6389219. 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-2156-2024&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-2156-2024&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-2156-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2156-2024 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)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2156-2024&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-2156-2024&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-2156-2024/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,
        "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."
    }
  ],
  "hasPart": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2156-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2156-2024",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "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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          "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": "Exactech, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-04-18",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) 200-03-26, UDI/DI 10885862039637, Lot Numbers:  6389536, 6389549, 6389551, 6389538, 6389540, 6389531, 6389537, 6389529, 6389534, 6389542, 6389545, 6711546, 6711550, 6389547, 6389548, 6389555, 6711540;   b) 200-03-29, UDI/DI 10885862039644, Lot Numbers:  6276447, 6276452, 6385318, 6385319, 6607740, 6385323, 6385304, 6385321, 6276446, 6276448, 6385300, 6276442, 6385310, 6385316, 6385325, 6607741, 7037109, 6276425, 6276429, 6276428, 6276433, 6276450, 6276453, 6607760, 6276437, 6276440, 6607751, 6607754, 6276426, 6276445, 6276449, 6607744, 6607759, 6276434, 6276435, 6276443, 6276451, 6385307;   c) 200-03-32, UDI/DI 10885862039651, Lot Numbers:  6385285, 6385286, 6844803, 6844831, 6385268, 6385278, 7043349, 7043358, 7043331, 6844822, 6385266, 6385269, 6385272, 6385277, 6385274, 7043330, 7043333, 7043336, 7043337, 7043342, 7043343, 7043356, 6385273, 6385281, 6385294, 6844804, 6844817, 6844818, 6844826;   d) 200-03-35, UDI/DI 10885862039668, Lot Numbers:  6711235, 6711254, 7044342, 7044351, 7044345, 6711236, 6711253, 7044338, 7044347, 7044349, 7044348, 6711245, 7044352, 7044336, 7044350;   e) 200-03-38, UDI/DI 10885862039675, Lot Numbers:  6401867, 6401876, 6401870, 7043457, 6401882, 6401868, 6401871, 7043466, 7043474, 6401858, 6401872, 7043460, 6923186, 6401873, 6923184, 6401855, 6401860, 6401877, 6401879, 7043459, 7043463;   f) 200-03-41, UDI/DI 10885862039682, Lot Numbers:  6389208, 6389211, 6389221, 6389216, 6389215, 6389220, 6389225, 6389213, 6389223, 6389224, 6389217, 6389226, 6389210, 6389222, 6389214, 6389207, 6389212, 6389219",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}