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  "@type": "schema:Dataset",
  "name": "HRIS ACET CUP CUT TIP 32X140   Part Number: 6210-5-200rker.    single-use, sterile surgical instruments used during hip arthroplasty",
  "description": "FDA recall Z-1000-2024 — Howmedica Osteonics Corp. is recalling HRIS ACET CUP CUT TIP 32X140   Part Number: 6210-5-200rker.    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",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "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-1000-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "HRIS ACET CUP CUT TIP 32X140   Part Number: 6210-5-200rker.    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-1000-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1000-2024: Howmedica Osteonics Corp. is recalling HRIS ACET CUP CUT TIP 32X140   Part Number: 6210-5-200rker.    single-use, sterile surgical instruments used during hip arthroplasty",
      "text": "The FDA logged enforcement record Z-1000-2024: Howmedica Osteonics Corp. is voluntarily recalling HRIS ACET CUP CUT TIP 32X140   Part Number: 6210-5-200rker.    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: 07613327144093 Lot Numbers: X22H11A1 X22H11 X22E19A X22E19D X22E19 X22C19 X22C19A1 X22C19A2 X22C19A3 X21M16A X21M16 X21K12 X21K12A X20T14A1 X20P04D X20P04A X20T14A2 X20P04 X20T14 X19P17 X19P05 X19M57 X19M55D X19M55A X19M55 X19D04A X19D03 X19D04 X18T45 X18S06A X18S06 X18S06D X18N50 X18E19KA X17V14D X17V14A X18E09A X18E09 X18E19KAA1 X18E19KAA2 X17T14 X17T13 X17T14A X17K16 X17L31 X16W10 X16V16 X16V41 X16V29 X16M13 X16L13 X16L12 X16H32 X16H19 X16E12 X16C06 X16A07 X15V08 X15V08A X15N27 X15M06 X15L22 X15L03 X9K29 X15E23 X15E22 X15A04 X9V15 X9S15 X9N52E X9N52 X9N13 X9K06 X9L11 X9E25A X9E25D X9C05 X9C05Y X8L03 X8L03A X7M04 X7M07A X7M07M X7M07 X7M06 X7M04A X7H21TD X7H21T X7H23 X7K17 X7H21 X7H27 X7H27A X7A13P X7A13 X7A13PA X5T77 X5M46 X5M46L X5H43A X5H43 X5M47E X5M47T X5M47 X5L45 X5E50. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": 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-1000-2024&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-1000-2024&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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    {
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      "name": "FDA classified recall Z-1000-2024 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
      },
      "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-1000-2024&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-1000-2024&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-1000-2024/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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        "groundingType": "Interpretation",
        "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-1000-2024",
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            "Value": "Z-1000-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "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,
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            "Field": "Recalling firm",
            "Value": "Howmedica Osteonics Corp.",
            "Status": "recorded"
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          "item": {
            "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: 07613327144093 Lot Numbers: X22H11A1 X22H11 X22E19A X22E19D X22E19 X22C19 X22C19A1 X22C19A2 X22C19A3 X21M16A X21M16 X21K12 X21K12A X20T14A1 X20P04D X20P04A X20T14A2 X20P04 X20T14 X19P17 X19P05 X19M57 X19M55D X19M55A X19M55 X19D04A X19D03 X19D04 X18T45 X18S06A X18S06 X18S06D X18N50 X18E19KA X17V14D X17V14A X18E09A X18E09 X18E19KAA1 X18E19KAA2 X17T14 X17T13 X17T14A X17K16 X17L31 X16W10 X16V16 X16V41 X16V29 X16M13 X16L13 X16L12 X16H32 X16H19 X16E12 X16C06 X16A07 X15V08 X15V08A X15N27 X15M06 X15L22 X15L03 X9K29 X15E23 X15E22 X15A04 X9V15 X9S15 X9N52E X9N52 X9N13 X9K06 X9L11 X9E25A X9E25D X9C05 X9C05Y X8L03 X8L03A X7M04 X7M07A X7M07M X7M07 X7M06 X7M04A X7H21TD X7H21T X7H23 X7K17 X7H21 X7H27 X7H27A X7A13P X7A13 X7A13PA X5T77 X5M46 X5M46L X5H43A X5H43 X5M47E X5M47T X5M47 X5L45 X5E50",
            "Status": "recorded"
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            "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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