{
  "@context": {
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    "@vocab": "https://schema.org/",
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0580-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Exactech Equinoxe Shoulder System, Catalog Numbers:    a)\t314-23-02,   b)\t314-23-03,   c)\t314-23-13,   d)\t314-23-14,   e)\t314-23-15,   f)\t314-24-22,   g)\t314-24-23,   h)\t314-24-24,   i)\t314-24-32,   j)\t314-24-33,   k)\t314-24-34,   l)\t314-24-35",
  "description": "FDA recall Z-0580-2024 — Exactech, Inc. is recalling Exactech Equinoxe Shoulder System, Catalog Numbers:    a)\t314-23-02,   b)\t314-23-03,   c)\t314-23-13,   d)\t314-23-14,   e)\t314-23-15,   f)\t314-24-22,   g)\t314-24-23,   h)\t314-24-24,   i)\t314-24-32,   j)\t314-24-33,   k)\t314-24-34,   l)\t314-24-35 (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-0580-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Exactech Equinoxe Shoulder System, Catalog Numbers:    a)\t314-23-02,   b)\t314-23-03,   c)\t314-23-13,   d)\t314-23-14,   e)\t314-23-15,   f)\t314-24-22,   g)\t314-24-23,   h)\t314-24-24,   i)\t314-24-32,   j)\t314-24-33,   k)\t314-24-34,   l)\t314-24-35",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Exactech, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0580-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0580-2024: Exactech, Inc. is recalling Exactech Equinoxe Shoulder System, Catalog Numbers:    a)\t314-23-02,   b)\t314-23-03,   c)\t314-23-13,   d)\t314-23-14,   e)\t314-23-15,   f)\t314-24-22,   g)\t314-24-23,   h)\t314-24-24,   i)\t314-24-32,   j)\t314-24-33,   k)\t314-24-34,   l)\t314-24-35",
      "text": "The FDA logged enforcement record Z-0580-2024: Exactech, Inc. is voluntarily recalling Exactech Equinoxe Shoulder System, Catalog Numbers:    a)\t314-23-02,   b)\t314-23-03,   c)\t314-23-13,   d)\t314-23-14,   e)\t314-23-15,   f)\t314-24-22,   g)\t314-24-23,   h)\t314-24-24,   i)\t314-24-32,   j)\t314-24-33,   k)\t314-24-34,   l)\t314-24-35 — 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) 314-23-02, GTIN 10885862585288, Serial Numbers:  A644041, A644042, A644043, A644044, A660121, A660122, A660124, A662676, A662681, A662684, A662685, A662688, A680284, A680285, A680288, A680289;  b) 314-23-03, GTIN 10885862585295, Serial Numbers:  A705013, A705015, A705017, A705019, A724643, A724644, A724645, A724649, A724650, A724653, A724654, A724655, A724660, A724662, A724664;  c) 314-23-13, GTIN 10885862585318, Serial Numbers:  A641342, A641343, A641348, A659643, A659645, A662713, A662714, A662715, A662716, A662717, A662718, A662722, A662728, A724502, A724505, A724509, A724512, A724519, A724520, A724521, A724522, A724529, A724531, A724535, A724542, A737352, A737356;  d) 314-23-14, GTIN 10885862585325, Serial Numbers:  A644055, A644056, A644057, A649227, A649231, A659611, A662730, A662731, A662732, A662733, A662734, A662736, A662737, A662743, A662744, A662745, A737404, A737408;  e) 314-23-15, GTIN 10885862585332, Serial Numbers:  A644011, A644012, A644013, A644015, A649151, A649157, A649158, A649160, A649161, A649162, A649164, A649165, A659613, A659614, A659615, A659616, A659617, A659620, A659622;  f) 314-24-22, GTIN 10885862585349, Serial Numbers:  A662708, A704921, A704924, A708554, A708559, A708560, A737109, A737114, A737115, A737117;  g) 314-24-23, GTIN 10885862585356, Serial Numbers:  A680327, A704932, A704936, A704939, A704941, A704943, A704945;    h) 314-24-24, GTIN 10885862585363, Serial Numbers:  A697922, A697923, A697928, A704996, A704997, A704998, A704999, A705000, A705001, A705002, A705003, A705004, A705005, A705007, A705009, A705011, A737098;  i) 314-24-32, GTIN 10885862585387, Serial Numbers:  A660114, A691515, A691522, A708328;  j) 314-24-33, GTIN 10885862585394, Serial Numbers:  A660130, A660135, A660137, A660139, A660140, A704661, A704662, A704665, A704667;  k) 314-24-34, GTIN 10885862585400, Serial Numbers:  A649166, A649168, A649169, A649170, A649175, A662702;  l) 314-24-35, GTIN 10885862585417, Serial Numbers:  A659658, A659663. 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-0580-2024&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-0580-2024&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-0580-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0580-2024 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-0580-2024&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-0580-2024&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-0580-2024/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-0580-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0580-2024",
            "Status": "recorded"
          }
        },
        {
          "@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) 314-23-02, GTIN 10885862585288, Serial Numbers:  A644041, A644042, A644043, A644044, A660121, A660122, A660124, A662676, A662681, A662684, A662685, A662688, A680284, A680285, A680288, A680289;  b) 314-23-03, GTIN 10885862585295, Serial Numbers:  A705013, A705015, A705017, A705019, A724643, A724644, A724645, A724649, A724650, A724653, A724654, A724655, A724660, A724662, A724664;  c) 314-23-13, GTIN 10885862585318, Serial Numbers:  A641342, A641343, A641348, A659643, A659645, A662713, A662714, A662715, A662716, A662717, A662718, A662722, A662728, A724502, A724505, A724509, A724512, A724519, A724520, A724521, A724522, A724529, A724531, A724535, A724542, A737352, A737356;  d) 314-23-14, GTIN 10885862585325, Serial Numbers:  A644055, A644056, A644057, A649227, A649231, A659611, A662730, A662731, A662732, A662733, A662734, A662736, A662737, A662743, A662744, A662745, A737404, A737408;  e) 314-23-15, GTIN 10885862585332, Serial Numbers:  A644011, A644012, A644013, A644015, A649151, A649157, A649158, A649160, A649161, A649162, A649164, A649165, A659613, A659614, A659615, A659616, A659617, A659620, A659622;  f) 314-24-22, GTIN 10885862585349, Serial Numbers:  A662708, A704921, A704924, A708554, A708559, A708560, A737109, A737114, A737115, A737117;  g) 314-24-23, GTIN 10885862585356, Serial Numbers:  A680327, A704932, A704936, A704939, A704941, A704943, A704945;    h) 314-24-24, GTIN 10885862585363, Serial Numbers:  A697922, A697923, A697928, A704996, A704997, A704998, A704999, A705000, A705001, A705002, A705003, A705004, A705005, A705007, A705009, A705011, A737098;  i) 314-24-32, GTIN 10885862585387, Serial Numbers:  A660114, A691515, A691522, A708328;  j) 314-24-33, GTIN 10885862585394, Serial Numbers:  A660130, A660135, A660137, A660139, A660140, A704661, A704662, A704665, A704667;  k) 314-24-34, GTIN 10885862585400, Serial Numbers:  A649166, A649168, A649169, A649170, A649175, A662702;  l) 314-24-35, GTIN 10885862585417, Serial Numbers:  A659658, A659663",
            "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"
          }
        }
      ]
    }
  ]
}