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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2615-2025.jsonld",
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  "name": "Ortoma Inserter Adapter OTD:  Inserter Adapter OTD Straight REF 30-201  Model Number: 2001  UDI-DI code: 07350137521019    Inserter Adapter OTD Pinnacle Straight REF 30-202  Model Number: 1001  UDI-DI code: 07350137520593    Reamer Adapter OTD REF 30-157  Model Number: 1003  UDI-DI code: 07350137520081    Inserter Adapter OTD REF 30-158  Model Number: 1004  UDI-DI code: 07350137520098    The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation.",
  "description": "FDA recall Z-2615-2025 — ORTOMA AB is recalling Ortoma Inserter Adapter OTD:  Inserter Adapter OTD Straight REF 30-201  Model Number: 2001  UDI-DI code: 07350137521019    Inserter Adapter OTD Pinnacle Straight REF 30-202  Model Number: 1001  UDI-DI code: 07350137520593    Reamer Adapter OTD REF 30-157  Model Number: 1003  UDI-DI code: 07350137520081    Inserter Adapter OTD REF 30-158  Model Number: 1004  UDI-DI code: 07350137520098    The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation. (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": "openFDA drug & device enforcement (recall) reports",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Ortoma Inserter Adapter OTD:  Inserter Adapter OTD Straight REF 30-201  Model Number: 2001  UDI-DI code: 07350137521019    Inserter Adapter OTD Pinnacle Straight REF 30-202  Model Number: 1001  UDI-DI code: 07350137520593    Reamer Adapter OTD REF 30-157  Model Number: 1003  UDI-DI code: 07350137520081    Inserter Adapter OTD REF 30-158  Model Number: 1004  UDI-DI code: 07350137520098    The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "ORTOMA AB"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2615-2025/enforcement-record",
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      "name": "FDA recall Z-2615-2025: ORTOMA AB is recalling Ortoma Inserter Adapter OTD:  Inserter Adapter OTD Straight REF 30-201  Model Number: 2001  UDI-DI code: 07350137521019    Inserter Adapter OTD Pinnacle Straight REF 30-202  Model Number: 1001  UDI-DI code: 07350137520593    Reamer Adapter OTD REF 30-157  Model Number: 1003  UDI-DI code: 07350137520081    Inserter Adapter OTD REF 30-158  Model Number: 1004  UDI-DI code: 07350137520098    The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation.",
      "text": "The FDA logged enforcement record Z-2615-2025: ORTOMA AB is voluntarily recalling Ortoma Inserter Adapter OTD:  Inserter Adapter OTD Straight REF 30-201  Model Number: 2001  UDI-DI code: 07350137521019    Inserter Adapter OTD Pinnacle Straight REF 30-202  Model Number: 1001  UDI-DI code: 07350137520593    Reamer Adapter OTD REF 30-157  Model Number: 1003  UDI-DI code: 07350137520081    Inserter Adapter OTD REF 30-158  Model Number: 1004  UDI-DI code: 07350137520098    The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation. — reason: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-07-28. Affected lots/codes: Model Number: 2001 Catalog Number: 30-201 UDI-DI code: 07350137521019 Lot Numbers: 20244803  Model Number: 1001 Catalog Number: 30-202 UDI-DI code: 07350137520593 Lot Numbers: 20245103 20245104 20245109  Model Number: 1003 Catalog Number: 30-157 UDI-DI code: 07350137520081 Lot Numbers: 20242001 20242008 20245119  Model Number: 1004 Catalog Number: 30-158 UDI-DI code: 07350137520098 Only distributed O.U.S.. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2615-2025&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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2615-2025/fda-classification",
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      "name": "FDA classified recall Z-2615-2025 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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      },
      "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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      "@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",
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        "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-2615-2025",
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            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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            "Value": "Class II",
            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
            "Value": "ORTOMA AB",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2025-07-28",
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            "Field": "Lot/code info",
            "Value": "Model Number: 2001 Catalog Number: 30-201 UDI-DI code: 07350137521019 Lot Numbers: 20244803  Model Number: 1001 Catalog Number: 30-202 UDI-DI code: 07350137520593 Lot Numbers: 20245103 20245104 20245109  Model Number: 1003 Catalog Number: 30-157 UDI-DI code: 07350137520081 Lot Numbers: 20242001 20242008 20245119  Model Number: 1004 Catalog Number: 30-158 UDI-DI code: 07350137520098 Only distributed O.U.S.",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden.",
            "Status": "recorded"
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