{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0148-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads    Part ID/Description:  18593\tHEAD FEMORAL 22MM -3  18594\tHEAD FEMORAL 22MM +0  19003\tHEAD FEMORAL 28MM-6  19004\tHEAD FEMORAL 28MM-3  19005\tHEAD FEMORAL 28MM+0  19006\tHEAD FEMORAL 28MM+3  19007\tHEAD FEMORAL 28MM+6  19008\tHEAD FEMORAL 28MM+9  19053\tHEAD FEMORAL 36MM -3  19054\tHEAD FEMORAL 36MM +0  19055\tHEAD FEMORAL 36MM +3  19056\tHEAD FEMORAL 36MM +6  19057\tHEAD FEMORAL 36MM +9  19130\tHEAD FEMORAL 32MM-6  19131\tHEAD FEMORAL 32MM-3  19132\tHEAD FEMORAL 32MM+0  19133\tHEAD FEMORAL 32MM +3  19134\tHEAD FEMORAL 32MM+6  19135\tHEAD FEMORAL 32MM +9",
  "description": "FDA recall Z-0148-2026 — BioPro, Inc. is recalling BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads    Part ID/Description:  18593\tHEAD FEMORAL 22MM -3  18594\tHEAD FEMORAL 22MM +0  19003\tHEAD FEMORAL 28MM-6  19004\tHEAD FEMORAL 28MM-3  19005\tHEAD FEMORAL 28MM+0  19006\tHEAD FEMORAL 28MM+3  19007\tHEAD FEMORAL 28MM+6  19008\tHEAD FEMORAL 28MM+9  19053\tHEAD FEMORAL 36MM -3  19054\tHEAD FEMORAL 36MM +0  19055\tHEAD FEMORAL 36MM +3  19056\tHEAD FEMORAL 36MM +6  19057\tHEAD FEMORAL 36MM +9  19130\tHEAD FEMORAL 32MM-6  19131\tHEAD FEMORAL 32MM-3  19132\tHEAD FEMORAL 32MM+0  19133\tHEAD FEMORAL 32MM +3  19134\tHEAD FEMORAL 32MM+6  19135\tHEAD FEMORAL 32MM +9 (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/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0148-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads    Part ID/Description:  18593\tHEAD FEMORAL 22MM -3  18594\tHEAD FEMORAL 22MM +0  19003\tHEAD FEMORAL 28MM-6  19004\tHEAD FEMORAL 28MM-3  19005\tHEAD FEMORAL 28MM+0  19006\tHEAD FEMORAL 28MM+3  19007\tHEAD FEMORAL 28MM+6  19008\tHEAD FEMORAL 28MM+9  19053\tHEAD FEMORAL 36MM -3  19054\tHEAD FEMORAL 36MM +0  19055\tHEAD FEMORAL 36MM +3  19056\tHEAD FEMORAL 36MM +6  19057\tHEAD FEMORAL 36MM +9  19130\tHEAD FEMORAL 32MM-6  19131\tHEAD FEMORAL 32MM-3  19132\tHEAD FEMORAL 32MM+0  19133\tHEAD FEMORAL 32MM +3  19134\tHEAD FEMORAL 32MM+6  19135\tHEAD FEMORAL 32MM +9",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "BioPro, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0148-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0148-2026: BioPro, Inc. is recalling BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads    Part ID/Description:  18593\tHEAD FEMORAL 22MM -3  18594\tHEAD FEMORAL 22MM +0  19003\tHEAD FEMORAL 28MM-6  19004\tHEAD FEMORAL 28MM-3  19005\tHEAD FEMORAL 28MM+0  19006\tHEAD FEMORAL 28MM+3  19007\tHEAD FEMORAL 28MM+6  19008\tHEAD FEMORAL 28MM+9  19053\tHEAD FEMORAL 36MM -3  19054\tHEAD FEMORAL 36MM +0  19055\tHEAD FEMORAL 36MM +3  19056\tHEAD FEMORAL 36MM +6  19057\tHEAD FEMORAL 36MM +9  19130\tHEAD FEMORAL 32MM-6  19131\tHEAD FEMORAL 32MM-3  19132\tHEAD FEMORAL 32MM+0  19133\tHEAD FEMORAL 32MM +3  19134\tHEAD FEMORAL 32MM+6  19135\tHEAD FEMORAL 32MM +9",
      "text": "The FDA logged enforcement record Z-0148-2026: BioPro, Inc. is voluntarily recalling BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads    Part ID/Description:  18593\tHEAD FEMORAL 22MM -3  18594\tHEAD FEMORAL 22MM +0  19003\tHEAD FEMORAL 28MM-6  19004\tHEAD FEMORAL 28MM-3  19005\tHEAD FEMORAL 28MM+0  19006\tHEAD FEMORAL 28MM+3  19007\tHEAD FEMORAL 28MM+6  19008\tHEAD FEMORAL 28MM+9  19053\tHEAD FEMORAL 36MM -3  19054\tHEAD FEMORAL 36MM +0  19055\tHEAD FEMORAL 36MM +3  19056\tHEAD FEMORAL 36MM +6  19057\tHEAD FEMORAL 36MM +9  19130\tHEAD FEMORAL 32MM-6  19131\tHEAD FEMORAL 32MM-3  19132\tHEAD FEMORAL 32MM+0  19133\tHEAD FEMORAL 32MM +3  19134\tHEAD FEMORAL 32MM+6  19135\tHEAD FEMORAL 32MM +9 — 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: Part ID/ UDI-DI:  18593 M20918593 18594 M20918594 19003 M20919003 19004 M20919004 19005 M20919005 19006 M20919006 19007 M20919007 19008 M20919008 19053 M20919053 19054 M20919054 19055 M20919055 19056 M20919056 19057 M20919057 19130 M20919130 19131 M20919131 19132 M20919132 19133 M20919133 19134 M20919134 19135 M20919135  All lots and serial numbers affected. 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-0148-2026&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-0148-2026&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-0148-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0148-2026 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",
      "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-0148-2026&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-0148-2026&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-0148-2026/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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0148-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0148-2026",
            "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": "BioPro, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-09-09",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Part ID/ UDI-DI:  18593 M20918593 18594 M20918594 19003 M20919003 19004 M20919004 19005 M20919005 19006 M20919006 19007 M20919007 19008 M20919008 19053 M20919053 19054 M20919054 19055 M20919055 19056 M20919056 19057 M20919057 19130 M20919130 19131 M20919131 19132 M20919132 19133 M20919133 19134 M20919134 19135 M20919135  All lots and serial numbers affected",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Domestic distribution to Texas and Michigan.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}