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  "name": "Iconix Knotless  1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520    Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521    The Iconix Knotless anchors are intended to be used for soft-tissue to  bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder.",
  "description": "FDA recall Z-0518-2024 — Riverpoint Medical, LLC is recalling Iconix Knotless  1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520    Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521    The Iconix Knotless anchors are intended to be used for soft-tissue to  bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. (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": "Iconix Knotless  1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520    Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521    The Iconix Knotless anchors are intended to be used for soft-tissue to  bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder.",
    "manufacturer": {
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      "name": "Riverpoint Medical, LLC"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0518-2024/enforcement-record",
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      "name": "FDA recall Z-0518-2024: Riverpoint Medical, LLC is recalling Iconix Knotless  1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520    Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521    The Iconix Knotless anchors are intended to be used for soft-tissue to  bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder.",
      "text": "The FDA logged enforcement record Z-0518-2024: Riverpoint Medical, LLC is voluntarily recalling Iconix Knotless  1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520    Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521    The Iconix Knotless anchors are intended to be used for soft-tissue to  bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. — reason: Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to suture breaks during use.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-25. Affected lots/codes: Product Code: 3911-7 14-520 UDI-DI Code: 00840277402172 Lot Number: 23080433  Product Code: 3911-7 14-521 UDI-DI Code: 00840277402189 Lot Number: 23081617. A RECORDED FDA enforcement action (occurred=true).",
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        "adjudged": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0518-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0518-2024&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."
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      "name": "FDA classified recall Z-0518-2024 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.",
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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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            "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": "Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to suture breaks during use.",
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            "Field": "Distribution pattern",
            "Value": "U.S. Nationwide distribution in the state of CA.",
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