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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0579-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Exactech Equinoxe Reverse Shoulder System, Catalog Numbers:    a)\t320-36-00,   b)\t320-36-03,   c)\t320-36-04,   d)\t320-36-10,   e)\t320-36-13,   f)\t320-38-00,   g)\t320-38-13,   h)\t320-40-00,   i)\t320-40-10,   j)\t320-42-00,   k)\t320-42-10,   l)\t320-42-13,   m)\t320-46-10,   n)\t320-46-13",
  "description": "FDA recall Z-0579-2024 — Exactech, Inc. is recalling Exactech Equinoxe Reverse Shoulder System, Catalog Numbers:    a)\t320-36-00,   b)\t320-36-03,   c)\t320-36-04,   d)\t320-36-10,   e)\t320-36-13,   f)\t320-38-00,   g)\t320-38-13,   h)\t320-40-00,   i)\t320-40-10,   j)\t320-42-00,   k)\t320-42-10,   l)\t320-42-13,   m)\t320-46-10,   n)\t320-46-13 (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": {
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      "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-0579-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Exactech Equinoxe Reverse Shoulder System, Catalog Numbers:    a)\t320-36-00,   b)\t320-36-03,   c)\t320-36-04,   d)\t320-36-10,   e)\t320-36-13,   f)\t320-38-00,   g)\t320-38-13,   h)\t320-40-00,   i)\t320-40-10,   j)\t320-42-00,   k)\t320-42-10,   l)\t320-42-13,   m)\t320-46-10,   n)\t320-46-13",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Exactech, Inc."
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0579-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0579-2024: Exactech, Inc. is recalling Exactech Equinoxe Reverse Shoulder System, Catalog Numbers:    a)\t320-36-00,   b)\t320-36-03,   c)\t320-36-04,   d)\t320-36-10,   e)\t320-36-13,   f)\t320-38-00,   g)\t320-38-13,   h)\t320-40-00,   i)\t320-40-10,   j)\t320-42-00,   k)\t320-42-10,   l)\t320-42-13,   m)\t320-46-10,   n)\t320-46-13",
      "text": "The FDA logged enforcement record Z-0579-2024: Exactech, Inc. is voluntarily recalling Exactech Equinoxe Reverse Shoulder System, Catalog Numbers:    a)\t320-36-00,   b)\t320-36-03,   c)\t320-36-04,   d)\t320-36-10,   e)\t320-36-13,   f)\t320-38-00,   g)\t320-38-13,   h)\t320-40-00,   i)\t320-40-10,   j)\t320-42-00,   k)\t320-42-10,   l)\t320-42-13,   m)\t320-46-10,   n)\t320-46-13 — 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) 320-36-00, GTIN 10885862086617, Serial Numbers:  A641190, A641191, A641194, A641202, A641203, A641215, A641221, A641222, A641223, A641224, A641225, A641228, A641229, A641230, A641232, A641233, A641235, A641237, A641238, A641239, A641240, A641241, A641242, A641244, A641245, A641246, A641247, A680944, A689543, A689544, A689545, A689549, A689553, A689557, A689560, A689565, A689572, A706598, A706612, A706630, A706631, A706639, A706641;    b) 320-36-03, GTIN 10885862086624, Serial Numbers:  A640183, A640186, A640188, A640190, A640193, A640195, A640196, A640198, A677718, A677727, A677728, A677731, A677732, A677751, A685284, A685289, A685290, A685291, A685292, A685295, A685296, A685298, A685299, A685300, A685301, A685303, A685305, A685306, A685310, A685312, A685315, A685317, A685318, A685319, A685320, A685323, A685326, A685327, A685337, A685338, A685346, A685350, A685351, A685361, A685362, A685363, A685369, A685375, A685377, A685379, A695083, A695088, A695098, A695107, A695120, A695122;  c) 320-36-04, GTIN 10885862086624, Serial Numbers:  A685325;  d) 320-36-10, GTIN 10885862086631, Serial Numbers:  A695123, A695124, A695125, A695126, A695127, A695129, A695130, A695131, A695132, A695137, A695140, A695146, A695150, A695151, A695152, A695154, A695155, A695157, A695159, A695160, A695161, A695162, A695165, A695166, A695167, A695168, A716197, A716219, A716230, A716231, A716232, A716233, A716234, A716236;  e) 320-36-13, GTIN 10885862086648, Serial Numbers:  A696430, A696435, A696436, A696438, A696441, A696443, A696444, A696445, A696446, A696447, A696449, A696450, A696452, A696455, A696458, A696459, A696460, A696461, A696462, A696466, A696469, A696471, A696472, A696473, A696474, A696475, A696477;  f) 320-38-00, GTIN 10885862086655, Serial Numbers:  A738779, A738799, A738822, A738823, A738846, A738847, A738848, A738849, A738850;  g) 320-38-13, GTIN 10885862086686, Serial Numbers:  A679891;  h) 320-40-00, GTIN 10885862535030, Serial Numbers:  A641613, A641619, A641623, A641624, A641626, A641629, A641631, A641632, A688976, A688977, A688981, A688982, A688983, A688984, A688985, A688986, A688989, A688990, A688991, A688992, A688993, A688994, A688997, A688999, A689001, A689002, A689003, A689004, A689008, A689011, A689015, A689016, A689017, A689018, A689019, A689021, A689022, A689023, A689025, A715756, A715757, A715758, A715760, A715762, A715763, A715764, A715766, A715768, A715771, A715775, A750496, A750497, A750499, A750502, A750511, A750524, A750529;  i) 320-40-10, GTIN 10885862535054, Serial Numbers:  A689439, A689441, A689442, A689445, A689448, A689449, A689452, A689453, A689456, A689459, A689461, A689465, A689475, A689476;  j) 320-42-00, GTIN 10885862086693, Serial Numbers:  A639962, A639964, A639965, A639966, A639967, A639977, A639978, A639979, A639984, A639986, A639989;  k) 320-42-10, GTIN 10885862086716, Serial Numbers:  A685535, A685539, A685551, A685557, A685568, A685573;  l) 320-42-13, GTIN 10885862086723, Serial Numbers:  A677654, A677663, A677675, A677683, A677690, A677691, A677692, A677698;  m) 320-46-10, GTIN 10885862086754, Serial Numbers:  A638847, A638848, A638849, A677703, A677704, A677707, A677708, A677712;  n) 320-46-13, GTIN 10885862086761, Serial Numbers:  A662094, A685620, A685624, A685627, A773694, A773700, A773702. 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-0579-2024&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-0579-2024&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-0579-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0579-2024 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-0579-2024&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-0579-2024&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-0579-2024/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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      "name": "FDA recall details — Z-0579-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0579-2024",
            "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"
          }
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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": "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) 320-36-00, GTIN 10885862086617, Serial Numbers:  A641190, A641191, A641194, A641202, A641203, A641215, A641221, A641222, A641223, A641224, A641225, A641228, A641229, A641230, A641232, A641233, A641235, A641237, A641238, A641239, A641240, A641241, A641242, A641244, A641245, A641246, A641247, A680944, A689543, A689544, A689545, A689549, A689553, A689557, A689560, A689565, A689572, A706598, A706612, A706630, A706631, A706639, A706641;    b) 320-36-03, GTIN 10885862086624, Serial Numbers:  A640183, A640186, A640188, A640190, A640193, A640195, A640196, A640198, A677718, A677727, A677728, A677731, A677732, A677751, A685284, A685289, A685290, A685291, A685292, A685295, A685296, A685298, A685299, A685300, A685301, A685303, A685305, A685306, A685310, A685312, A685315, A685317, A685318, A685319, A685320, A685323, A685326, A685327, A685337, A685338, A685346, A685350, A685351, A685361, A685362, A685363, A685369, A685375, A685377, A685379, A695083, A695088, A695098, A695107, A695120, A695122;  c) 320-36-04, GTIN 10885862086624, Serial Numbers:  A685325;  d) 320-36-10, GTIN 10885862086631, Serial Numbers:  A695123, A695124, A695125, A695126, A695127, A695129, A695130, A695131, A695132, A695137, A695140, A695146, A695150, A695151, A695152, A695154, A695155, A695157, A695159, A695160, A695161, A695162, A695165, A695166, A695167, A695168, A716197, A716219, A716230, A716231, A716232, A716233, A716234, A716236;  e) 320-36-13, GTIN 10885862086648, Serial Numbers:  A696430, A696435, A696436, A696438, A696441, A696443, A696444, A696445, A696446, A696447, A696449, A696450, A696452, A696455, A696458, A696459, A696460, A696461, A696462, A696466, A696469, A696471, A696472, A696473, A696474, A696475, A696477;  f) 320-38-00, GTIN 10885862086655, Serial Numbers:  A738779, A738799, A738822, A738823, A738846, A738847, A738848, A738849, A738850;  g) 320-38-13, GTIN 10885862086686, Serial Numbers:  A679891;  h) 320-40-00, GTIN 10885862535030, Serial Numbers:  A641613, A641619, A641623, A641624, A641626, A641629, A641631, A641632, A688976, A688977, A688981, A688982, A688983, A688984, A688985, A688986, A688989, A688990, A688991, A688992, A688993, A688994, A688997, A688999, A689001, A689002, A689003, A689004, A689008, A689011, A689015, A689016, A689017, A689018, A689019, A689021, A689022, A689023, A689025, A715756, A715757, A715758, A715760, A715762, A715763, A715764, A715766, A715768, A715771, A715775, A750496, A750497, A750499, A750502, A750511, A750524, A750529;  i) 320-40-10, GTIN 10885862535054, Serial Numbers:  A689439, A689441, A689442, A689445, A689448, A689449, A689452, A689453, A689456, A689459, A689461, A689465, A689475, A689476;  j) 320-42-00, GTIN 10885862086693, Serial Numbers:  A639962, A639964, A639965, A639966, A639967, A639977, A639978, A639979, A639984, A639986, A639989;  k) 320-42-10, GTIN 10885862086716, Serial Numbers:  A685535, A685539, A685551, A685557, A685568, A685573;  l) 320-42-13, GTIN 10885862086723, Serial Numbers:  A677654, A677663, A677675, A677683, A677690, A677691, A677692, A677698;  m) 320-46-10, GTIN 10885862086754, Serial Numbers:  A638847, A638848, A638849, A677703, A677704, A677707, A677708, A677712;  n) 320-46-13, GTIN 10885862086761, Serial Numbers:  A662094, A685620, A685624, A685627, A773694, A773700, A773702",
            "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"
          }
        }
      ]
    }
  ]
}