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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2422-2025.jsonld",
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  "name": "Brand Name: Atlantis IO FLO  Product Name: Atlantis IO FLO-S Kit  Model/Catalog Number: A04S / 6802034  Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model.  Component: not a component",
  "description": "FDA recall Z-2422-2025 — Dentsply IH, Inc. is recalling Brand Name: Atlantis IO FLO  Product Name: Atlantis IO FLO-S Kit  Model/Catalog Number: A04S / 6802034  Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model.  Component: not a component (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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    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Atlantis IO FLO  Product Name: Atlantis IO FLO-S Kit  Model/Catalog Number: A04S / 6802034  Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model.  Component: not a component",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Dentsply IH, Inc."
    }
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  "claims": [
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2422-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2422-2025: Dentsply IH, Inc. is recalling Brand Name: Atlantis IO FLO  Product Name: Atlantis IO FLO-S Kit  Model/Catalog Number: A04S / 6802034  Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model.  Component: not a component",
      "text": "The FDA logged enforcement record Z-2422-2025: Dentsply IH, Inc. is voluntarily recalling Brand Name: Atlantis IO FLO  Product Name: Atlantis IO FLO-S Kit  Model/Catalog Number: A04S / 6802034  Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model.  Component: not a component — reason: The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling).  The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations.  This equates to approximately 1mm difference in depth of engagement.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-07-24. Affected lots/codes: Catalog / Ref #: 68020034; UDI: 07392532249440; Lot #s: 10515863, 10512084, 10505543, 10556741;. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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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-2422-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-2422-2025&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."
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      "name": "FDA classified recall Z-2422-2025 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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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-2422-2025&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-2422-2025/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": {
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        "adjudged": false,
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        "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-2422-2025",
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            "Value": "Z-2422-2025",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "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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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Dentsply IH, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling).  The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations.  This equates to approximately 1mm difference in depth of engagement.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-07-24",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "Catalog / Ref #: 68020034; UDI: 07392532249440; Lot #s: 10515863, 10512084, 10505543, 10556741;",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution in the states of IL, LA, MA, MN, MO, ND, NJ, NM, OH, OK, PA, TX, WV and the countries of AT, AU, BE, CA, DE, DK, ES, FI, FR, IT, JP, NL, NO, PL, QA, SE, UA, UK.",
            "Status": "recorded"
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