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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0582-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Exactech Optetrak Knee System, Catalog Numbers:    a)\t200-02-26,   b)\t200-02-29,   c)\t200-02-32,   d)\t200-02-35,   e)\t200-02-38,   f)\t200-02-41,   g)\t200-03-32,   h)\t200-07-29,   i)\t200-07-32,   j)\t200-07-35,   k)\t204-21-13,   l)\t204-22-26,   m)\t208-23-18,   n)\t208-24-13",
  "description": "FDA recall Z-0582-2024 — Exactech, Inc. is recalling Exactech Optetrak Knee System, Catalog Numbers:    a)\t200-02-26,   b)\t200-02-29,   c)\t200-02-32,   d)\t200-02-35,   e)\t200-02-38,   f)\t200-02-41,   g)\t200-03-32,   h)\t200-07-29,   i)\t200-07-32,   j)\t200-07-35,   k)\t204-21-13,   l)\t204-22-26,   m)\t208-23-18,   n)\t208-24-13 (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-0582-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Exactech Optetrak Knee System, Catalog Numbers:    a)\t200-02-26,   b)\t200-02-29,   c)\t200-02-32,   d)\t200-02-35,   e)\t200-02-38,   f)\t200-02-41,   g)\t200-03-32,   h)\t200-07-29,   i)\t200-07-32,   j)\t200-07-35,   k)\t204-21-13,   l)\t204-22-26,   m)\t208-23-18,   n)\t208-24-13",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Exactech, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0582-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0582-2024: Exactech, Inc. is recalling Exactech Optetrak Knee System, Catalog Numbers:    a)\t200-02-26,   b)\t200-02-29,   c)\t200-02-32,   d)\t200-02-35,   e)\t200-02-38,   f)\t200-02-41,   g)\t200-03-32,   h)\t200-07-29,   i)\t200-07-32,   j)\t200-07-35,   k)\t204-21-13,   l)\t204-22-26,   m)\t208-23-18,   n)\t208-24-13",
      "text": "The FDA logged enforcement record Z-0582-2024: Exactech, Inc. is voluntarily recalling Exactech Optetrak Knee System, Catalog Numbers:    a)\t200-02-26,   b)\t200-02-29,   c)\t200-02-32,   d)\t200-02-35,   e)\t200-02-38,   f)\t200-02-41,   g)\t200-03-32,   h)\t200-07-29,   i)\t200-07-32,   j)\t200-07-35,   k)\t204-21-13,   l)\t204-22-26,   m)\t208-23-18,   n)\t208-24-13 — reason: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-21. Affected lots/codes: a) 200-02-26, GTIN 10885862039576, Serial Numbers:  A736412;  b) 200-02-29, GTIN 10885862039583, Serial Numbers:  A689481, A689501, A689515, A708024, A708032, A708035, A708038, A708050, A708077, A708082, A708092, A708100, A708111;  c) 200-02-32, GTIN 10885862039590, Serial Numbers:  A679528, A679530, A679539, A679547, A679550, A684414, A715781, A715800, A715804, A715824, A715828, A715924;  d) 200-02-35, GTIN 10885862039606, Serial Numbers:  A661377, A661380, A661381, A661391, A661395;  e) 200-02-38, GTIN 10885862039613, Serial Numbers:  A708298, A708300, A708301, A708304, A708316, A708320, A708324;  f) 200-02-41, GTIN 10885862039620, Serial Numbers:  A665568, A665569, A665575, A665578, A665581, A665582, A665584, A665585, A665586, A665588, A665592, A699428, A699429, A699433, A699437, A699444, A699449, A699450, A699455;  g) 200-03-32, GTIN 10885862039651, Serial Numbers:  A773440, A773441, A773470;  h) 200-07-29, GTIN  10885862314277, Serial Numbers:  A656015, A656020, A656022, A656026, A656030, A656031, A656032, A656033, A656035, A656038, A679488, A679495, A679498, A679508, A679516;  i) 200-07-32, GTIN 10885862314284, Serial Numbers:  A664708, A680022, A680031, A680034, A680039, A680041, A680044, A680049, A680071, A680072, A680073;  j) 200-07-35, GTIN 10885862314291, Serial Numbers:  A655621, A655637, A655640, A655641, A655656, A655657, A655659, A655667, A655676, A679417, A679418, A679421, A679453, A679462, A681114, A681132, A681135;  k) 204-21-13, GTIN 10885862048165, Serial Numbers:  A679949;  l) 204-22-26, GTIN 10885862048288, Serial Numbers:  A770137;  m) 208-23-18, GTIN 10885862054289, Serial Numbers:  A655685, A655691;  n) 208-24-13, GTIN 10885862054340, Serial Numbers:  A655589. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-0582-2024&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-0582-2024&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-0582-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0582-2024 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
      },
      "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-0582-2024&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-0582-2024&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-0582-2024/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": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0582-2024",
      "numberOfItems": 9,
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          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0582-2024",
            "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"
          }
        },
        {
          "@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": "Exactech, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-11-21",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) 200-02-26, GTIN 10885862039576, Serial Numbers:  A736412;  b) 200-02-29, GTIN 10885862039583, Serial Numbers:  A689481, A689501, A689515, A708024, A708032, A708035, A708038, A708050, A708077, A708082, A708092, A708100, A708111;  c) 200-02-32, GTIN 10885862039590, Serial Numbers:  A679528, A679530, A679539, A679547, A679550, A684414, A715781, A715800, A715804, A715824, A715828, A715924;  d) 200-02-35, GTIN 10885862039606, Serial Numbers:  A661377, A661380, A661381, A661391, A661395;  e) 200-02-38, GTIN 10885862039613, Serial Numbers:  A708298, A708300, A708301, A708304, A708316, A708320, A708324;  f) 200-02-41, GTIN 10885862039620, Serial Numbers:  A665568, A665569, A665575, A665578, A665581, A665582, A665584, A665585, A665586, A665588, A665592, A699428, A699429, A699433, A699437, A699444, A699449, A699450, A699455;  g) 200-03-32, GTIN 10885862039651, Serial Numbers:  A773440, A773441, A773470;  h) 200-07-29, GTIN  10885862314277, Serial Numbers:  A656015, A656020, A656022, A656026, A656030, A656031, A656032, A656033, A656035, A656038, A679488, A679495, A679498, A679508, A679516;  i) 200-07-32, GTIN 10885862314284, Serial Numbers:  A664708, A680022, A680031, A680034, A680039, A680041, A680044, A680049, A680071, A680072, A680073;  j) 200-07-35, GTIN 10885862314291, Serial Numbers:  A655621, A655637, A655640, A655641, A655656, A655657, A655659, A655667, A655676, A679417, A679418, A679421, A679453, A679462, A681114, A681132, A681135;  k) 204-21-13, GTIN 10885862048165, Serial Numbers:  A679949;  l) 204-22-26, GTIN 10885862048288, Serial Numbers:  A770137;  m) 208-23-18, GTIN 10885862054289, Serial Numbers:  A655685, A655691;  n) 208-24-13, GTIN 10885862054340, Serial Numbers:  A655589",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}