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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1101-2025.jsonld",
  "@type": "schema:Dataset",
  "name": ". Nobel Biocare N1 TiUltra TCC RP 4.0x9mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm    Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous  dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function",
  "description": "FDA recall Z-1101-2025 — Nobel Biocare is recalling . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm    Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous  dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function (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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1101-2025&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": ". Nobel Biocare N1 TiUltra TCC RP 4.0x9mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm    Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous  dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Nobel Biocare"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1101-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1101-2025: Nobel Biocare is recalling . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm    Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous  dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function",
      "text": "The FDA logged enforcement record Z-1101-2025: Nobel Biocare is voluntarily recalling . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm    Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous  dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function — reason: Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-01-10. Affected lots/codes: Nobel Biocare N1 TiUltra TCC RP 4.0x 9mm Catalog Number: 300861 UDI-DI code:  07332747161731 Lot Numbers: 12253672 12253673  Nobel Biocare N1 TiUltra TCC RP 4.0x11mm Catalog Number: 300862 UDI-DI code:  07332747161748 Lot Numbers: 12253448 12254209  Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Catalog Number: 300863 UDI-DI code: 07332747161755 Lot Numbers: 12253620 12254213. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
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        "adjudged": 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-1101-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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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-1101-2025 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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        "value": "Class II",
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      },
      "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-1101-2025/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.",
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        "adjudicator": null
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      "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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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
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            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.",
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            "Value": "Nobel Biocare N1 TiUltra TCC RP 4.0x 9mm Catalog Number: 300861 UDI-DI code:  07332747161731 Lot Numbers: 12253672 12253673  Nobel Biocare N1 TiUltra TCC RP 4.0x11mm Catalog Number: 300862 UDI-DI code:  07332747161748 Lot Numbers: 12253448 12254209  Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Catalog Number: 300863 UDI-DI code: 07332747161755 Lot Numbers: 12253620 12254213",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S. Nationwide distribution in the states of CA, FL, IL, MA, NJ, NY, OH, PA, UT, VA and WA.",
            "Status": "recorded"
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