{
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2687-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Multiple Digital Analog Products labeled as:  NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703  Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303  3i Certain-compatible 5.0mm Digital Analog, REF 9001903  3i Certain-compatible 6.0mm Digital Analog, REF 9002003  Astra-compatible 3.0mm Digital Analog, REF 9002103  Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203  Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203  BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203  Legacy-compatible 3.0mm Digital Analog, REF 9005303  Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403  Legacy-compatible 3.5mm Digital Analog, REF 9005503  Legacy-compatible 5.7mm Digital Analog, REF 9008503  Astra EV 4.8mm Milled Titanium Abutment REF 9006767    Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.",
  "description": "FDA recall Z-2687-2024 — Preat Corp is recalling Multiple Digital Analog Products labeled as:  NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703  Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303  3i Certain-compatible 5.0mm Digital Analog, REF 9001903  3i Certain-compatible 6.0mm Digital Analog, REF 9002003  Astra-compatible 3.0mm Digital Analog, REF 9002103  Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203  Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203  BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203  Legacy-compatible 3.0mm Digital Analog, REF 9005303  Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403  Legacy-compatible 3.5mm Digital Analog, REF 9005503  Legacy-compatible 5.7mm Digital Analog, REF 9008503  Astra EV 4.8mm Milled Titanium Abutment REF 9006767    Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory. (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/",
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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-2687-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Multiple Digital Analog Products labeled as:  NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703  Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303  3i Certain-compatible 5.0mm Digital Analog, REF 9001903  3i Certain-compatible 6.0mm Digital Analog, REF 9002003  Astra-compatible 3.0mm Digital Analog, REF 9002103  Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203  Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203  BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203  Legacy-compatible 3.0mm Digital Analog, REF 9005303  Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403  Legacy-compatible 3.5mm Digital Analog, REF 9005503  Legacy-compatible 5.7mm Digital Analog, REF 9008503  Astra EV 4.8mm Milled Titanium Abutment REF 9006767    Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Preat Corp"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2687-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2687-2024: Preat Corp is recalling Multiple Digital Analog Products labeled as:  NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703  Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303  3i Certain-compatible 5.0mm Digital Analog, REF 9001903  3i Certain-compatible 6.0mm Digital Analog, REF 9002003  Astra-compatible 3.0mm Digital Analog, REF 9002103  Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203  Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203  BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203  Legacy-compatible 3.0mm Digital Analog, REF 9005303  Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403  Legacy-compatible 3.5mm Digital Analog, REF 9005503  Legacy-compatible 5.7mm Digital Analog, REF 9008503  Astra EV 4.8mm Milled Titanium Abutment REF 9006767    Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.",
      "text": "The FDA logged enforcement record Z-2687-2024: Preat Corp is voluntarily recalling Multiple Digital Analog Products labeled as:  NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703  Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303  3i Certain-compatible 5.0mm Digital Analog, REF 9001903  3i Certain-compatible 6.0mm Digital Analog, REF 9002003  Astra-compatible 3.0mm Digital Analog, REF 9002103  Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203  Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203  BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203  Legacy-compatible 3.0mm Digital Analog, REF 9005303  Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403  Legacy-compatible 3.5mm Digital Analog, REF 9005503  Legacy-compatible 5.7mm Digital Analog, REF 9008503  Astra EV 4.8mm Milled Titanium Abutment REF 9006767    Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory. — reason: Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-25. Affected lots/codes: Model Numbers: 9000703, 9001303, 9001903, 9002003, 9002103, 9002203, 9002203, 9005203, 9005203, 9005303, 9005403, 9005503, 9008503, 9006767  UDI-DI codes: 00842092178690, 00842092181898, 00842092181959, 00842092178737, 00842092178775, 00842092178812, 00842092178812, 00842092178898, 00842092178898, 00842092178997, 00842092178928, 00842092178959, 00842092182130  Lot Numbers: 250219, 248890, 251432, 250602, 250418, 250213, 251459, 249071, 250335, 250223, 250336, 249510, 250215.. 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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        "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-2687-2024&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-2687-2024&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-2687-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2687-2024 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
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      "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-2687-2024&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-2687-2024&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-2687-2024/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,
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      "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-2687-2024",
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            "Value": "Z-2687-2024",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "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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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Preat Corp",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-06-25",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Model Numbers: 9000703, 9001303, 9001903, 9002003, 9002103, 9002203, 9002203, 9005203, 9005203, 9005303, 9005403, 9005503, 9008503, 9006767  UDI-DI codes: 00842092178690, 00842092181898, 00842092181959, 00842092178737, 00842092178775, 00842092178812, 00842092178812, 00842092178898, 00842092178898, 00842092178997, 00842092178928, 00842092178959, 00842092182130  Lot Numbers: 250219, 248890, 251432, 250602, 250418, 250213, 251459, 249071, 250335, 250223, 250336, 249510, 250215.",
            "Status": "recorded"
          }
        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S. Nationwide distribution in the states of  AK, AZ, FL, GA, IL, LA, MD, MI, MN, NY, OH, OK, OR, PA, RI, TX, UT, and WA",
            "Status": "recorded"
          }
        }
      ]
    }
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}