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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0999-2024.jsonld",
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  "name": "HRIS ACET CUP CUT TIP 26X140    Part Number: 6210-5-100.    single-use, sterile surgical instruments used during hip arthroplasty",
  "description": "FDA recall Z-0999-2024 — Howmedica Osteonics Corp. is recalling HRIS ACET CUP CUT TIP 26X140    Part Number: 6210-5-100.    single-use, sterile surgical instruments used during hip arthroplasty (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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    "creator": {
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      "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-0999-2024&lang=eng",
  "about": {
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    "name": "HRIS ACET CUP CUT TIP 26X140    Part Number: 6210-5-100.    single-use, sterile surgical instruments used during hip arthroplasty",
    "manufacturer": {
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      "name": "Howmedica Osteonics Corp."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0999-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0999-2024: Howmedica Osteonics Corp. is recalling HRIS ACET CUP CUT TIP 26X140    Part Number: 6210-5-100.    single-use, sterile surgical instruments used during hip arthroplasty",
      "text": "The FDA logged enforcement record Z-0999-2024: Howmedica Osteonics Corp. is voluntarily recalling HRIS ACET CUP CUT TIP 26X140    Part Number: 6210-5-100.    single-use, sterile surgical instruments used during hip arthroplasty — reason: Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-22. Affected lots/codes: GTIN: 07613327144086 Lot NUmbers: X22V12 X22V12A X22V12D X22T13A X22T13 X22T13D X22M09D X22M09 X22M09A X21T01K X21T01M X21T01 X20T19 X20T17A X21E23E X21E23D X21E23 X21E23A X20T17 X20T19M X20C37 X20C03A X20C03 X19N44 X19M03A X19M03 X19M02 X19K25A X19K25 X19K24 X19T10 X19K01A X19K01 X19K01D X18S14A X18T28A X18T28 X18T28A1 X18S14D X18N49 X18S14 X17N33R X18C24 X18E04 X18E04A X17N33 X17N33D X17N33A X17L11 X17L11D X17L11A X16T27 X16V17 X16W06 X16W08 X16H36 X16H37A X16H37 X16E15J X16E15K X16C22 X16A06 X15V17 X15V17A X15S26 X15S26A X15M17A X15M17 X15N14A X15N14J X15L12 X15H18 X15K15 X9W16 X9W16E X9V09 X9N60M X9T20 X9T20A X9S16 X9N60P X9N25 X9N29 X9L15J X9K31 X9K09 X9E24 X9A03A X9A03 X9A03D X9A03E X8T01 X8T01A X8L28TT X8L28T X8L28 X8L28A X7M11 X7H42A X7M22 X7M11M X7K10 X7H42 X5E15 X5M45V X5T70 X5M45K X5M45 X5M45L X5H45A X5H45 X5H12 X5H12D X5L22 X5L22W X5L22W1 X5C35. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
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        "supported": true,
        "adjudged": true,
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        "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-0999-2024/fda-classification",
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      "name": "FDA classified recall Z-0999-2024 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",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "AdjudicativeAct",
        "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-0999-2024&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-0999-2024&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-0999-2024/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": {
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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-0999-2024",
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            "Value": "Z-0999-2024",
            "Status": "recorded"
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          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Howmedica Osteonics Corp.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-12-22",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN: 07613327144086 Lot NUmbers: X22V12 X22V12A X22V12D X22T13A X22T13 X22T13D X22M09D X22M09 X22M09A X21T01K X21T01M X21T01 X20T19 X20T17A X21E23E X21E23D X21E23 X21E23A X20T17 X20T19M X20C37 X20C03A X20C03 X19N44 X19M03A X19M03 X19M02 X19K25A X19K25 X19K24 X19T10 X19K01A X19K01 X19K01D X18S14A X18T28A X18T28 X18T28A1 X18S14D X18N49 X18S14 X17N33R X18C24 X18E04 X18E04A X17N33 X17N33D X17N33A X17L11 X17L11D X17L11A X16T27 X16V17 X16W06 X16W08 X16H36 X16H37A X16H37 X16E15J X16E15K X16C22 X16A06 X15V17 X15V17A X15S26 X15S26A X15M17A X15M17 X15N14A X15N14J X15L12 X15H18 X15K15 X9W16 X9W16E X9V09 X9N60M X9T20 X9T20A X9S16 X9N60P X9N25 X9N29 X9L15J X9K31 X9K09 X9E24 X9A03A X9A03 X9A03D X9A03E X8T01 X8T01A X8L28TT X8L28T X8L28 X8L28A X7M11 X7H42A X7M22 X7M11M X7K10 X7H42 X5E15 X5M45V X5T70 X5M45K X5M45 X5M45L X5H45A X5H45 X5H12 X5H12D X5L22 X5L22W X5L22W1 X5C35",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, S. Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.",
            "Status": "recorded"
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