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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1215-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers:  REF: PE11151211 -  11x150mm,\tPE11151213 -  13x150mm, \tPE11151215 - 15x150mm,\tPE11151217 - 17x150mm,\tPE11151411 - 11x200mm,\tPE11151413 - 13x200mm,\tPE11151415 - 15x200mm,\tPE11151417 - 17x200mm,",
  "description": "FDA recall Z-1215-2024 — United Orthopedic Corporation is recalling USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers:  REF: PE11151211 -  11x150mm,\tPE11151213 -  13x150mm, \tPE11151215 - 15x150mm,\tPE11151217 - 17x150mm,\tPE11151411 - 11x200mm,\tPE11151413 - 13x200mm,\tPE11151415 - 15x200mm,\tPE11151417 - 17x200mm, (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/",
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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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1215-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers:  REF: PE11151211 -  11x150mm,\tPE11151213 -  13x150mm, \tPE11151215 - 15x150mm,\tPE11151217 - 17x150mm,\tPE11151411 - 11x200mm,\tPE11151413 - 13x200mm,\tPE11151415 - 15x200mm,\tPE11151417 - 17x200mm,",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "United Orthopedic Corporation"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1215-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1215-2024: United Orthopedic Corporation is recalling USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers:  REF: PE11151211 -  11x150mm,\tPE11151213 -  13x150mm, \tPE11151215 - 15x150mm,\tPE11151217 - 17x150mm,\tPE11151411 - 11x200mm,\tPE11151413 - 13x200mm,\tPE11151415 - 15x200mm,\tPE11151417 - 17x200mm,",
      "text": "The FDA logged enforcement record Z-1215-2024: United Orthopedic Corporation is voluntarily recalling USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers:  REF: PE11151211 -  11x150mm,\tPE11151213 -  13x150mm, \tPE11151215 - 15x150mm,\tPE11151217 - 17x150mm,\tPE11151411 - 11x200mm,\tPE11151413 - 13x200mm,\tPE11151415 - 15x200mm,\tPE11151417 - 17x200mm, — reason: Their is a potential that the implant curved stem  may be oriented incorrectly.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-03. Affected lots/codes: UDI(s): 04719872153894, 04719872153924, 04719872153863, 04719872153870, 04719872149866, 04719872153900, 04719872153917, 04719872153887 Lot Number(s): 15E198AA 15E198AA12 15E198AA22 15E198AA23 15E198S11 15E198S12 15E198W11 15E198W111 15E198X 15E198X21 15E198Y 15E198Y11 15E198Z 15E198Z111 15E198Z22 15E198Z3 16C168H 16C168H21 16C168H3 16C168J 16C168R1 17H618E 17H618E1 17H618E2 18A004A 18A004B 18A004B111 18A004C2 18A004C31 18A004D 18A004D1 18A004D21 18A004D22 18A004E 18A004E1 18A004E112 18A004F 18A004F111 18A004F211 18A004F212 18A004G 18A004G1 18A004G111 18A004G2 18A004G31 18A004H 18A004H212 18A004W11 20G378F2 20H134A 20H134A11 20H134A3 20H134B2 21D124A 21D124A1 21D124A2 21D124C1 21D124C11 21D512C 21D512C1 21D512C11 21D512D 21D512D2 21D512E2 21D512E3 21D512F1 21G420E1 21G420K1 21G420K11 21G420M1 21G420M2 21H573H1 21M254A 21M254B 21M254B1 21M254K 21M254X 21M254Y 21M254Y2 21M254Z 22F087AG 22F087AH 22F087AH1 22F087AJ 22F087AJ1 22K035C 22M166H 22M166J 22M166K 22M166K1 23A240C 23A240E 23A240E1 23A240F 23B622AA 23B622AB 23B622AC 23B622AD 23B622AW 23B622H 23B622J 23B622K 23B622L 23B622M 23B622N 23B622P 23B622Q 23B622R 23B622S 23B622W 23B622X 23B622Y 23B622Z 23C803W 23C803X 23D393L 23D393M 23D393N. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
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        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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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-1215-2024&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-1215-2024&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-1215-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1215-2024 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": {
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-1215-2024&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-1215-2024/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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        "supported": true,
        "adjudged": false,
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      "grounding": {
        "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-1215-2024",
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            "Value": "Z-1215-2024",
            "Status": "recorded"
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            "Value": "Devices",
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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "United Orthopedic Corporation",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Their is a potential that the implant curved stem  may be oriented incorrectly.",
            "Status": "recorded"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-01-03",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI(s): 04719872153894, 04719872153924, 04719872153863, 04719872153870, 04719872149866, 04719872153900, 04719872153917, 04719872153887 Lot Number(s): 15E198AA 15E198AA12 15E198AA22 15E198AA23 15E198S11 15E198S12 15E198W11 15E198W111 15E198X 15E198X21 15E198Y 15E198Y11 15E198Z 15E198Z111 15E198Z22 15E198Z3 16C168H 16C168H21 16C168H3 16C168J 16C168R1 17H618E 17H618E1 17H618E2 18A004A 18A004B 18A004B111 18A004C2 18A004C31 18A004D 18A004D1 18A004D21 18A004D22 18A004E 18A004E1 18A004E112 18A004F 18A004F111 18A004F211 18A004F212 18A004G 18A004G1 18A004G111 18A004G2 18A004G31 18A004H 18A004H212 18A004W11 20G378F2 20H134A 20H134A11 20H134A3 20H134B2 21D124A 21D124A1 21D124A2 21D124C1 21D124C11 21D512C 21D512C1 21D512C11 21D512D 21D512D2 21D512E2 21D512E3 21D512F1 21G420E1 21G420K1 21G420K11 21G420M1 21G420M2 21H573H1 21M254A 21M254B 21M254B1 21M254K 21M254X 21M254Y 21M254Y2 21M254Z 22F087AG 22F087AH 22F087AH1 22F087AJ 22F087AJ1 22K035C 22M166H 22M166J 22M166K 22M166K1 23A240C 23A240E 23A240E1 23A240F 23B622AA 23B622AB 23B622AC 23B622AD 23B622AW 23B622H 23B622J 23B622K 23B622L 23B622M 23B622N 23B622P 23B622Q 23B622R 23B622S 23B622W 23B622X 23B622Y 23B622Z 23C803W 23C803X 23D393L 23D393M 23D393N",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US: CA,KY, MI, IN, TN, CO, FL, TX, NV,  OUS: Switzerland, United Kingdom, Malaysia, Philippines, Taiwan",
            "Status": "recorded"
          }
        }
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