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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0893-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Brand Name: Pillar\" SA PTC Spacer System  Product Name: Pillar\" SA PTC Spacer System  Model/Catalog Number: 39-9012SP\t33W X 28L X 12.5H, 7DEG PTC IMPLANT;  39-9014SP\t33W X 28L X 14H, 7DEG PTC IMPLANT;  39-9016SP\t33W X 28L X 16H, 7DEG PTC IMPLANT;  39-9018SP\t33W X 28L X 18H, 7DEG PTC IMPLANT;  39-9212SP\t33W X 28L X 12.5H, 12DEG PTC IMPLANT;  39-9214SP\t33W X 28L X 14H, 12DEG PTC IMPLANT;  39-9216SP\t33W X 28L X 16H, 12DEG PTC IMPLANT;  39-9218SP\t33W X 28L X 18H, 12DEG PTC IMPLANT;  39-2012SP\t37W X 28L X 12.5H, 7DEG PTC IMPLANT;  39-2014SP\t37W X 28L X 14H, 7DEG PTC IMPLANT;  39-2016SP\t37W X 28L X 16H, 7DEG PTC IMPLANT;  39-2018SP\t37W X 28L X 18H, 7DEG PTC IMPLANT;  39-2212SP\t37W X 28L X 12.5H, 12DEG PTC IMPLANT;  39-2214SP\t37W X 28L X 14H, 12DEG PTC IMPLANT;  39-2216SP\t37W X 28L X 16H, 12DEG PTC IMPLANT;  39-2218SP\t37W X 28L X 18H, 12DEG PTC IMPLANT;",
  "description": "FDA recall Z-0893-2026 — Orthofix U.S. LLC is recalling Brand Name: Pillar\" SA PTC Spacer System  Product Name: Pillar\" SA PTC Spacer System  Model/Catalog Number: 39-9012SP\t33W X 28L X 12.5H, 7DEG PTC IMPLANT;  39-9014SP\t33W X 28L X 14H, 7DEG PTC IMPLANT;  39-9016SP\t33W X 28L X 16H, 7DEG PTC IMPLANT;  39-9018SP\t33W X 28L X 18H, 7DEG PTC IMPLANT;  39-9212SP\t33W X 28L X 12.5H, 12DEG PTC IMPLANT;  39-9214SP\t33W X 28L X 14H, 12DEG PTC IMPLANT;  39-9216SP\t33W X 28L X 16H, 12DEG PTC IMPLANT;  39-9218SP\t33W X 28L X 18H, 12DEG PTC IMPLANT;  39-2012SP\t37W X 28L X 12.5H, 7DEG PTC IMPLANT;  39-2014SP\t37W X 28L X 14H, 7DEG PTC IMPLANT;  39-2016SP\t37W X 28L X 16H, 7DEG PTC IMPLANT;  39-2018SP\t37W X 28L X 18H, 7DEG PTC IMPLANT;  39-2212SP\t37W X 28L X 12.5H, 12DEG PTC IMPLANT;  39-2214SP\t37W X 28L X 14H, 12DEG PTC IMPLANT;  39-2216SP\t37W X 28L X 16H, 12DEG PTC IMPLANT;  39-2218SP\t37W X 28L X 18H, 12DEG PTC IMPLANT; (Devices, Class III). 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-0893-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Pillar\" SA PTC Spacer System  Product Name: Pillar\" SA PTC Spacer System  Model/Catalog Number: 39-9012SP\t33W X 28L X 12.5H, 7DEG PTC IMPLANT;  39-9014SP\t33W X 28L X 14H, 7DEG PTC IMPLANT;  39-9016SP\t33W X 28L X 16H, 7DEG PTC IMPLANT;  39-9018SP\t33W X 28L X 18H, 7DEG PTC IMPLANT;  39-9212SP\t33W X 28L X 12.5H, 12DEG PTC IMPLANT;  39-9214SP\t33W X 28L X 14H, 12DEG PTC IMPLANT;  39-9216SP\t33W X 28L X 16H, 12DEG PTC IMPLANT;  39-9218SP\t33W X 28L X 18H, 12DEG PTC IMPLANT;  39-2012SP\t37W X 28L X 12.5H, 7DEG PTC IMPLANT;  39-2014SP\t37W X 28L X 14H, 7DEG PTC IMPLANT;  39-2016SP\t37W X 28L X 16H, 7DEG PTC IMPLANT;  39-2018SP\t37W X 28L X 18H, 7DEG PTC IMPLANT;  39-2212SP\t37W X 28L X 12.5H, 12DEG PTC IMPLANT;  39-2214SP\t37W X 28L X 14H, 12DEG PTC IMPLANT;  39-2216SP\t37W X 28L X 16H, 12DEG PTC IMPLANT;  39-2218SP\t37W X 28L X 18H, 12DEG PTC IMPLANT;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Orthofix U.S. LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0893-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0893-2026: Orthofix U.S. LLC is recalling Brand Name: Pillar\" SA PTC Spacer System  Product Name: Pillar\" SA PTC Spacer System  Model/Catalog Number: 39-9012SP\t33W X 28L X 12.5H, 7DEG PTC IMPLANT;  39-9014SP\t33W X 28L X 14H, 7DEG PTC IMPLANT;  39-9016SP\t33W X 28L X 16H, 7DEG PTC IMPLANT;  39-9018SP\t33W X 28L X 18H, 7DEG PTC IMPLANT;  39-9212SP\t33W X 28L X 12.5H, 12DEG PTC IMPLANT;  39-9214SP\t33W X 28L X 14H, 12DEG PTC IMPLANT;  39-9216SP\t33W X 28L X 16H, 12DEG PTC IMPLANT;  39-9218SP\t33W X 28L X 18H, 12DEG PTC IMPLANT;  39-2012SP\t37W X 28L X 12.5H, 7DEG PTC IMPLANT;  39-2014SP\t37W X 28L X 14H, 7DEG PTC IMPLANT;  39-2016SP\t37W X 28L X 16H, 7DEG PTC IMPLANT;  39-2018SP\t37W X 28L X 18H, 7DEG PTC IMPLANT;  39-2212SP\t37W X 28L X 12.5H, 12DEG PTC IMPLANT;  39-2214SP\t37W X 28L X 14H, 12DEG PTC IMPLANT;  39-2216SP\t37W X 28L X 16H, 12DEG PTC IMPLANT;  39-2218SP\t37W X 28L X 18H, 12DEG PTC IMPLANT;",
      "text": "The FDA logged enforcement record Z-0893-2026: Orthofix U.S. LLC is voluntarily recalling Brand Name: Pillar\" SA PTC Spacer System  Product Name: Pillar\" SA PTC Spacer System  Model/Catalog Number: 39-9012SP\t33W X 28L X 12.5H, 7DEG PTC IMPLANT;  39-9014SP\t33W X 28L X 14H, 7DEG PTC IMPLANT;  39-9016SP\t33W X 28L X 16H, 7DEG PTC IMPLANT;  39-9018SP\t33W X 28L X 18H, 7DEG PTC IMPLANT;  39-9212SP\t33W X 28L X 12.5H, 12DEG PTC IMPLANT;  39-9214SP\t33W X 28L X 14H, 12DEG PTC IMPLANT;  39-9216SP\t33W X 28L X 16H, 12DEG PTC IMPLANT;  39-9218SP\t33W X 28L X 18H, 12DEG PTC IMPLANT;  39-2012SP\t37W X 28L X 12.5H, 7DEG PTC IMPLANT;  39-2014SP\t37W X 28L X 14H, 7DEG PTC IMPLANT;  39-2016SP\t37W X 28L X 16H, 7DEG PTC IMPLANT;  39-2018SP\t37W X 28L X 18H, 7DEG PTC IMPLANT;  39-2212SP\t37W X 28L X 12.5H, 12DEG PTC IMPLANT;  39-2214SP\t37W X 28L X 14H, 12DEG PTC IMPLANT;  39-2216SP\t37W X 28L X 16H, 12DEG PTC IMPLANT;  39-2218SP\t37W X 28L X 18H, 12DEG PTC IMPLANT; — reason: Labeling contains claims that are not consistently  present.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-11-03. Affected lots/codes: Lot Code: All Lot Codes/ UDI: 39-9012SP 18257200112630 39-9014SP 18257200112647 39-9016SP 18257200112654 39-9018SP 18257200112661 39-9212SP 18257200112678 39-9214SP 18257200112685 39-9216SP 18257200112692 39-9218SP 18257200112708 39-2012SP 18257200112715 39-2014SP 18257200112722 39-2016SP 18257200112739 39-2018SP 18257200112746 39-2212SP 18257200112753 39-2214SP 18257200112760 39-2216SP 18257200112777 39-2218SP 18257200112784. 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-0893-2026&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-0893-2026&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-0893-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0893-2026 as Class III",
      "text": "The FDA assigned this recall Class III: Class III — the FDA judged the product is unlikely to cause 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-0893-2026&lang=eng",
        "value": "Class III",
        "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-0893-2026&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-0893-2026/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": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0893-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0893-2026",
            "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 III",
            "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": "Orthofix U.S. LLC",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Labeling contains claims that are not consistently  present.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-11-03",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Lot Code: All Lot Codes/ UDI: 39-9012SP 18257200112630 39-9014SP 18257200112647 39-9016SP 18257200112654 39-9018SP 18257200112661 39-9212SP 18257200112678 39-9214SP 18257200112685 39-9216SP 18257200112692 39-9218SP 18257200112708 39-2012SP 18257200112715 39-2014SP 18257200112722 39-2016SP 18257200112739 39-2018SP 18257200112746 39-2212SP 18257200112753 39-2214SP 18257200112760 39-2216SP 18257200112777 39-2218SP 18257200112784",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}