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  "name": "Neodent GM X 6mm Engaging Titanium Base, REF: 9007162",
  "description": "FDA recall Z-1285-2023 — Preat Corp is recalling Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 (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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      "name": "FDA recall Z-1285-2023: Preat Corp is recalling Neodent GM X 6mm Engaging Titanium Base, REF: 9007162",
      "text": "The FDA logged enforcement record Z-1285-2023: Preat Corp is voluntarily recalling Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 — reason: Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-21. Affected lots/codes: UDI: 00842092161326, Lots: 211891 and 211912. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1285-2023 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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      "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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      "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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            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of TX, OR, UT, NY.",
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