{
  "@context": {
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    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
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    "occurred": "au:occurred",
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  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1426-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S;     JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S",
  "description": "FDA recall Z-1426-2023 — SPINEART SA is recalling JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S;     JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1426-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S;     JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "SPINEART SA"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1426-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1426-2023: SPINEART SA is recalling JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S;     JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S",
      "text": "The FDA logged enforcement record Z-1426-2023: SPINEART SA is voluntarily recalling JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S;     JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S — reason: JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar  Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-03-16. Affected lots/codes: REF/UDI-DI/Lot: JLT-PL 02 08-S/07640178987388/4-8826, 5-4142, 5-5377, 5-0643, 5-2431;   JLT-PL 02 10-S/07640178987395/6-5488, 6-6556, 5-0644, 6-4734, 6-4735, 5-5378, 6-3211;  JLT-PL 02 12-S/07640178987401/6-5489, 6-6558, 6-7645, 6-8734, 6-4732, 4-8828, 5-5379, 6-4733;   JLT-PL 02 14-S/07640178987418/5-8439, 4-8829, 6-0714, 5-5380;  JLT-PL 02 16-S/07640178987425/4-8830, 5-4145, 6-3217, 6-0726, 6-5490;   JLT-PL 04 08-S/07640178987456/4-8845, 5-4146, 6-0725;   JLT-PL 04 10-S/07640178987463/4-8831, 5-4147, 6-0722;  JLT-PL 04 12-S/07640178987470/4-8832, 5-4148, 5-8438, 6-0721, 6-3209;  JLT-PL 04 14-S/07640178987487/4-3861, 4-8833, 5-4149;  JLT-PL 04 16-S/07640178987494/5-4150;  JLT-PL 04 18-S/07640178987500/5-4151. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "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-1426-2023&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-1426-2023&lang=eng"
        }
      },
      "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-1426-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1426-2023 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-1426-2023&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-1426-2023&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-1426-2023/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,
        "operative": true
      },
      "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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1426-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1426-2023",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "SPINEART SA",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar  Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-03-16",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "REF/UDI-DI/Lot: JLT-PL 02 08-S/07640178987388/4-8826, 5-4142, 5-5377, 5-0643, 5-2431;   JLT-PL 02 10-S/07640178987395/6-5488, 6-6556, 5-0644, 6-4734, 6-4735, 5-5378, 6-3211;  JLT-PL 02 12-S/07640178987401/6-5489, 6-6558, 6-7645, 6-8734, 6-4732, 4-8828, 5-5379, 6-4733;   JLT-PL 02 14-S/07640178987418/5-8439, 4-8829, 6-0714, 5-5380;  JLT-PL 02 16-S/07640178987425/4-8830, 5-4145, 6-3217, 6-0726, 6-5490;   JLT-PL 04 08-S/07640178987456/4-8845, 5-4146, 6-0725;   JLT-PL 04 10-S/07640178987463/4-8831, 5-4147, 6-0722;  JLT-PL 04 12-S/07640178987470/4-8832, 5-4148, 5-8438, 6-0721, 6-3209;  JLT-PL 04 14-S/07640178987487/4-3861, 4-8833, 5-4149;  JLT-PL 04 16-S/07640178987494/5-4150;  JLT-PL 04 18-S/07640178987500/5-4151",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of NH, TX, CA, VA, IL, RI, NC, AZ.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}