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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0726-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code:  BASEPLATE D.25MM REGULAR/1975.14.500,  BASEPLATE D.28MM REGULAR/1975.14.800,  BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510,  BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810,  BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615,  BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815,  BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865,  BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620,  BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820,  BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870",
  "description": "FDA recall Z-0726-2024 — Limacorporate S.p.A is recalling PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code:  BASEPLATE D.25MM REGULAR/1975.14.500,  BASEPLATE D.28MM REGULAR/1975.14.800,  BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510,  BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810,  BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615,  BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815,  BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865,  BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620,  BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820,  BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870 (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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "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-0726-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code:  BASEPLATE D.25MM REGULAR/1975.14.500,  BASEPLATE D.28MM REGULAR/1975.14.800,  BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510,  BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810,  BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615,  BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815,  BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865,  BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620,  BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820,  BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Limacorporate S.p.A"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0726-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0726-2024: Limacorporate S.p.A is recalling PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code:  BASEPLATE D.25MM REGULAR/1975.14.500,  BASEPLATE D.28MM REGULAR/1975.14.800,  BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510,  BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810,  BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615,  BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815,  BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865,  BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620,  BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820,  BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870",
      "text": "The FDA logged enforcement record Z-0726-2024: Limacorporate S.p.A is voluntarily recalling PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code:  BASEPLATE D.25MM REGULAR/1975.14.500,  BASEPLATE D.28MM REGULAR/1975.14.800,  BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510,  BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810,  BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615,  BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815,  BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865,  BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620,  BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820,  BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870 — reason: Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-08-29. Affected lots/codes: Product Code/UDI-DI: 1975.14.500/08033390244824, 1975.14.800/08033390244893, 1975.14.510/08033390231299, 1975.14.810/08033390244909, 1975.14.615/08033390244848, 1975.14.815/08033390244916, 1975.14.865/08033390244930, 1975.14.620/08033390231312, 1975.14.820/08033390244923, 1975.14.870/08033390244947. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "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-0726-2024&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-0726-2024&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0726-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0726-2024 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",
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      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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        "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-0726-2024&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-0726-2024&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-0726-2024/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)",
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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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      "name": "FDA recall details — Z-0726-2024",
      "numberOfItems": 9,
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            "Value": "Z-0726-2024",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Limacorporate S.p.A",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-08-29",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Product Code/UDI-DI: 1975.14.500/08033390244824, 1975.14.800/08033390244893, 1975.14.510/08033390231299, 1975.14.810/08033390244909, 1975.14.615/08033390244848, 1975.14.815/08033390244916, 1975.14.865/08033390244930, 1975.14.620/08033390231312, 1975.14.820/08033390244923, 1975.14.870/08033390244947",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US: IL, MO, CA, IN, MI, OK",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}