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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0153-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "BioPro Femoral Head     Product ID/Description  14089\tHEAD FEMORAL 28 SH LT  14090\tHEAD FEMORAL 28 MD LT  14091\tHEAD FEMORAL 28 LG LT  14094\tHEAD FEMORAL 32 SH LT  14095\tHEAD FEMORAL 32 MD LT  14096\tHEAD FEMORAL 32 LG LT",
  "description": "FDA recall Z-0153-2026 — BioPro, Inc. is recalling BioPro Femoral Head     Product ID/Description  14089\tHEAD FEMORAL 28 SH LT  14090\tHEAD FEMORAL 28 MD LT  14091\tHEAD FEMORAL 28 LG LT  14094\tHEAD FEMORAL 32 SH LT  14095\tHEAD FEMORAL 32 MD LT  14096\tHEAD FEMORAL 32 LG LT (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-0153-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BioPro Femoral Head     Product ID/Description  14089\tHEAD FEMORAL 28 SH LT  14090\tHEAD FEMORAL 28 MD LT  14091\tHEAD FEMORAL 28 LG LT  14094\tHEAD FEMORAL 32 SH LT  14095\tHEAD FEMORAL 32 MD LT  14096\tHEAD FEMORAL 32 LG LT",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "BioPro, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0153-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0153-2026: BioPro, Inc. is recalling BioPro Femoral Head     Product ID/Description  14089\tHEAD FEMORAL 28 SH LT  14090\tHEAD FEMORAL 28 MD LT  14091\tHEAD FEMORAL 28 LG LT  14094\tHEAD FEMORAL 32 SH LT  14095\tHEAD FEMORAL 32 MD LT  14096\tHEAD FEMORAL 32 LG LT",
      "text": "The FDA logged enforcement record Z-0153-2026: BioPro, Inc. is voluntarily recalling BioPro Femoral Head     Product ID/Description  14089\tHEAD FEMORAL 28 SH LT  14090\tHEAD FEMORAL 28 MD LT  14091\tHEAD FEMORAL 28 LG LT  14094\tHEAD FEMORAL 32 SH LT  14095\tHEAD FEMORAL 32 MD LT  14096\tHEAD FEMORAL 32 LG LT — 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 2025-09-09. Affected lots/codes: Product ID/UDI-DI  14089 M20914089 14090 M20914090 14091 M20914091 14094 M20914094 14095 M20914095 14096 M20914096  All lots, all serial numbers. 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-0153-2026&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-0153-2026&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-0153-2026/fda-classification",
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      "name": "FDA classified recall Z-0153-2026 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.",
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      "reviewStatus": "current",
      "commercialInfluence": false,
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        "supported": true,
        "adjudged": true,
        "operative": true
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        "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-0153-2026&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-0153-2026&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-0153-2026/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-0153-2026",
      "numberOfItems": 9,
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            "Value": "Z-0153-2026",
            "Status": "recorded"
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            "Value": "Devices",
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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "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": "BioPro, 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": "2025-09-09",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Product ID/UDI-DI  14089 M20914089 14090 M20914090 14091 M20914091 14094 M20914094 14095 M20914095 14096 M20914096  All lots, all serial numbers",
            "Status": "recorded"
          }
        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Domestic distribution to Texas and Michigan.",
            "Status": "recorded"
          }
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}