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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1083-2026.jsonld",
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  "name": "Brand Name: PALACOS  Product Name: PALACOS MV pro 40; PALACOS MV pro 80  Model/Catalog Number: 5150633; 5150635  Software Version: N/A  Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application  system, suitable for use with or without vacuum (ready to mix).  Component: N/A",
  "description": "FDA recall Z-1083-2026 — Heraeus Medical GmbH (Dental Division) is recalling Brand Name: PALACOS  Product Name: PALACOS MV pro 40; PALACOS MV pro 80  Model/Catalog Number: 5150633; 5150635  Software Version: N/A  Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application  system, suitable for use with or without vacuum (ready to mix).  Component: N/A (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": "Brand Name: PALACOS  Product Name: PALACOS MV pro 40; PALACOS MV pro 80  Model/Catalog Number: 5150633; 5150635  Software Version: N/A  Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application  system, suitable for use with or without vacuum (ready to mix).  Component: N/A",
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      "name": "Heraeus Medical GmbH (Dental Division)"
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      "name": "FDA recall Z-1083-2026: Heraeus Medical GmbH (Dental Division) is recalling Brand Name: PALACOS  Product Name: PALACOS MV pro 40; PALACOS MV pro 80  Model/Catalog Number: 5150633; 5150635  Software Version: N/A  Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application  system, suitable for use with or without vacuum (ready to mix).  Component: N/A",
      "text": "The FDA logged enforcement record Z-1083-2026: Heraeus Medical GmbH (Dental Division) is voluntarily recalling Brand Name: PALACOS  Product Name: PALACOS MV pro 40; PALACOS MV pro 80  Model/Catalog Number: 5150633; 5150635  Software Version: N/A  Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application  system, suitable for use with or without vacuum (ready to mix).  Component: N/A — reason: increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-09. Affected lots/codes: Lot Code: UDI-DI: 04260102135338; 04260102135369. A RECORDED FDA enforcement action (occurred=true).",
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        "supported": true,
        "adjudged": true,
        "operative": true
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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-1083-2026&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-1083-2026&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-1083-2026 as 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."
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    {
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      "@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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        "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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            "Status": "recorded"
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            "Field": "Recalling firm",
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            "Field": "Reason",
            "Value": "increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.",
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            "Field": "Distribution pattern",
            "Value": "International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.",
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