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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0432-2026.jsonld",
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  "name": "Brand Name: Klassic BiPolar Head    Model/Catalog Number:   3205.41.022\tKlassic BiPolar Head, 41 mm OD, 22 mm Head;  3205.42.022\tKlassic BiPolar Head, 42 mm OD, 22 mm Head;  3205.43.022\tKlassic BiPolar Head, 43 mm OD, 22 mm Head;  3205.44.028\tKlassic BiPolar Head, 44 mm OD, 28 mm Head;  3205.45.028\tKlassic BiPolar Head, 45 mm OD, 28 mm Head;  3205.46.028\tKlassic BiPolar Head, 46 mm OD, 28 mm Head;  3205.47.028\tKlassic BiPolar Head, 47 mm OD, 28 mm Head;  3205.48.028\tKlassic BiPolar Head, 48 mm OD, 28 mm Head;  3205.49.028\tKlassic BiPolar Head, 49 mm OD, 28 mm Head;  3205.50.028\tKlassic BiPolar Head, 50 mm OD, 28 mm Head;  3205.51.028\tKlassic BiPolar Head, 51 mm OD, 28 mm Head;  3205.52.028\tKlassic BiPolar Head, 52 mm OD, 28 mm Head;  3205.53.028\tKlassic BiPolar Head, 53 mm OD, 28 mm Head;  3205.54.028\tKlassic BiPolar Head, 54 mm OD, 28 mm Head;  3205.55.028\tKlassic BiPolar Head, 55 mm OD, 28 mm Head;  3205.56.028\tKlassic BiPolar Head, 56 mm OD, 28 mm Head;  3205.58.028\tKlassic BiPolar Head, 58 mm OD, 28 mm Head;  3205.60.028\tKlassic BiPolar Head, 60 mm OD, 28 mm Head",
  "description": "FDA recall Z-0432-2026 — Total Joint Orthopedics, Inc. is recalling Brand Name: Klassic BiPolar Head    Model/Catalog Number:   3205.41.022\tKlassic BiPolar Head, 41 mm OD, 22 mm Head;  3205.42.022\tKlassic BiPolar Head, 42 mm OD, 22 mm Head;  3205.43.022\tKlassic BiPolar Head, 43 mm OD, 22 mm Head;  3205.44.028\tKlassic BiPolar Head, 44 mm OD, 28 mm Head;  3205.45.028\tKlassic BiPolar Head, 45 mm OD, 28 mm Head;  3205.46.028\tKlassic BiPolar Head, 46 mm OD, 28 mm Head;  3205.47.028\tKlassic BiPolar Head, 47 mm OD, 28 mm Head;  3205.48.028\tKlassic BiPolar Head, 48 mm OD, 28 mm Head;  3205.49.028\tKlassic BiPolar Head, 49 mm OD, 28 mm Head;  3205.50.028\tKlassic BiPolar Head, 50 mm OD, 28 mm Head;  3205.51.028\tKlassic BiPolar Head, 51 mm OD, 28 mm Head;  3205.52.028\tKlassic BiPolar Head, 52 mm OD, 28 mm Head;  3205.53.028\tKlassic BiPolar Head, 53 mm OD, 28 mm Head;  3205.54.028\tKlassic BiPolar Head, 54 mm OD, 28 mm Head;  3205.55.028\tKlassic BiPolar Head, 55 mm OD, 28 mm Head;  3205.56.028\tKlassic BiPolar Head, 56 mm OD, 28 mm Head;  3205.58.028\tKlassic BiPolar Head, 58 mm OD, 28 mm Head;  3205.60.028\tKlassic BiPolar Head, 60 mm OD, 28 mm Head (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Klassic BiPolar Head    Model/Catalog Number:   3205.41.022\tKlassic BiPolar Head, 41 mm OD, 22 mm Head;  3205.42.022\tKlassic BiPolar Head, 42 mm OD, 22 mm Head;  3205.43.022\tKlassic BiPolar Head, 43 mm OD, 22 mm Head;  3205.44.028\tKlassic BiPolar Head, 44 mm OD, 28 mm Head;  3205.45.028\tKlassic BiPolar Head, 45 mm OD, 28 mm Head;  3205.46.028\tKlassic BiPolar Head, 46 mm OD, 28 mm Head;  3205.47.028\tKlassic BiPolar Head, 47 mm OD, 28 mm Head;  3205.48.028\tKlassic BiPolar Head, 48 mm OD, 28 mm Head;  3205.49.028\tKlassic BiPolar Head, 49 mm OD, 28 mm Head;  3205.50.028\tKlassic BiPolar Head, 50 mm OD, 28 mm Head;  3205.51.028\tKlassic BiPolar Head, 51 mm OD, 28 mm Head;  3205.52.028\tKlassic BiPolar Head, 52 mm OD, 28 mm Head;  3205.53.028\tKlassic BiPolar Head, 53 mm OD, 28 mm Head;  3205.54.028\tKlassic BiPolar Head, 54 mm OD, 28 mm Head;  3205.55.028\tKlassic BiPolar Head, 55 mm OD, 28 mm Head;  3205.56.028\tKlassic BiPolar Head, 56 mm OD, 28 mm Head;  3205.58.028\tKlassic BiPolar Head, 58 mm OD, 28 mm Head;  3205.60.028\tKlassic BiPolar Head, 60 mm OD, 28 mm Head",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Total Joint Orthopedics, Inc."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0432-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0432-2026: Total Joint Orthopedics, Inc. is recalling Brand Name: Klassic BiPolar Head    Model/Catalog Number:   3205.41.022\tKlassic BiPolar Head, 41 mm OD, 22 mm Head;  3205.42.022\tKlassic BiPolar Head, 42 mm OD, 22 mm Head;  3205.43.022\tKlassic BiPolar Head, 43 mm OD, 22 mm Head;  3205.44.028\tKlassic BiPolar Head, 44 mm OD, 28 mm Head;  3205.45.028\tKlassic BiPolar Head, 45 mm OD, 28 mm Head;  3205.46.028\tKlassic BiPolar Head, 46 mm OD, 28 mm Head;  3205.47.028\tKlassic BiPolar Head, 47 mm OD, 28 mm Head;  3205.48.028\tKlassic BiPolar Head, 48 mm OD, 28 mm Head;  3205.49.028\tKlassic BiPolar Head, 49 mm OD, 28 mm Head;  3205.50.028\tKlassic BiPolar Head, 50 mm OD, 28 mm Head;  3205.51.028\tKlassic BiPolar Head, 51 mm OD, 28 mm Head;  3205.52.028\tKlassic BiPolar Head, 52 mm OD, 28 mm Head;  3205.53.028\tKlassic BiPolar Head, 53 mm OD, 28 mm Head;  3205.54.028\tKlassic BiPolar Head, 54 mm OD, 28 mm Head;  3205.55.028\tKlassic BiPolar Head, 55 mm OD, 28 mm Head;  3205.56.028\tKlassic BiPolar Head, 56 mm OD, 28 mm Head;  3205.58.028\tKlassic BiPolar Head, 58 mm OD, 28 mm Head;  3205.60.028\tKlassic BiPolar Head, 60 mm OD, 28 mm Head",
      "text": "The FDA logged enforcement record Z-0432-2026: Total Joint Orthopedics, Inc. is voluntarily recalling Brand Name: Klassic BiPolar Head    Model/Catalog Number:   3205.41.022\tKlassic BiPolar Head, 41 mm OD, 22 mm Head;  3205.42.022\tKlassic BiPolar Head, 42 mm OD, 22 mm Head;  3205.43.022\tKlassic BiPolar Head, 43 mm OD, 22 mm Head;  3205.44.028\tKlassic BiPolar Head, 44 mm OD, 28 mm Head;  3205.45.028\tKlassic BiPolar Head, 45 mm OD, 28 mm Head;  3205.46.028\tKlassic BiPolar Head, 46 mm OD, 28 mm Head;  3205.47.028\tKlassic BiPolar Head, 47 mm OD, 28 mm Head;  3205.48.028\tKlassic BiPolar Head, 48 mm OD, 28 mm Head;  3205.49.028\tKlassic BiPolar Head, 49 mm OD, 28 mm Head;  3205.50.028\tKlassic BiPolar Head, 50 mm OD, 28 mm Head;  3205.51.028\tKlassic BiPolar Head, 51 mm OD, 28 mm Head;  3205.52.028\tKlassic BiPolar Head, 52 mm OD, 28 mm Head;  3205.53.028\tKlassic BiPolar Head, 53 mm OD, 28 mm Head;  3205.54.028\tKlassic BiPolar Head, 54 mm OD, 28 mm Head;  3205.55.028\tKlassic BiPolar Head, 55 mm OD, 28 mm Head;  3205.56.028\tKlassic BiPolar Head, 56 mm OD, 28 mm Head;  3205.58.028\tKlassic BiPolar Head, 58 mm OD, 28 mm Head;  3205.60.028\tKlassic BiPolar Head, 60 mm OD, 28 mm Head — reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-23. Affected lots/codes: Part Number/UDI/Lot Number: 3205.41.022 00814703011931 3205.42.022 00814703011948 3205.43.022 00814703011955 3205.44.028 00814703011962 3205.45.028 00814703011979 3205.46.028 00814703011986 3205.47.028 00814703011993 3205.48.028 00814703012006 3205.49.028 00814703012013 3205.50.028 00814703012020 3205.51.028 00814703012037 3205.52.028 00814703012044 3205.53.028 00814703012051 3205.54.028 00814703012068 3205.55.028 00814703012075 3205.56.028 00814703012082 3205.58.028 00814703012105 3205.60.028 00814703012129. 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-0432-2026&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-0432-2026&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-0432-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0432-2026 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",
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class II",
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          "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-0432-2026&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-0432-2026/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."
    }
  ],
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      "name": "FDA recall details — Z-0432-2026",
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            "Field": "Recall number",
            "Value": "Z-0432-2026",
            "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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          "position": 4,
          "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": "Total Joint Orthopedics, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.",
            "Status": "recorded"
          }
        },
        {
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          "item": {
            "Field": "Initiated",
            "Value": "2025-09-23",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Part Number/UDI/Lot Number: 3205.41.022 00814703011931 3205.42.022 00814703011948 3205.43.022 00814703011955 3205.44.028 00814703011962 3205.45.028 00814703011979 3205.46.028 00814703011986 3205.47.028 00814703011993 3205.48.028 00814703012006 3205.49.028 00814703012013 3205.50.028 00814703012020 3205.51.028 00814703012037 3205.52.028 00814703012044 3205.53.028 00814703012051 3205.54.028 00814703012068 3205.55.028 00814703012075 3205.56.028 00814703012082 3205.58.028 00814703012105 3205.60.028 00814703012129",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of Ohio, Texas, Florida, Georgia, and North Carolina.",
            "Status": "recorded"
          }
        }
      ]
    }
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}