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  "name": "Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:     1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030.    2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035.    3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040.    4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045.    5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050.    6. POLYAXIAL SCREW, CC, 6.5mm X 30mm; Item Number: TL1-10765030.    7. POLYAXIAL SCREW, CC, 6.5mm X 35mm; Item Number: TL1-10765035.    8. POLYAXIAL SCREW, CC, 6.5mm X 40mm; Item Number: TL1-10765040.    9. POLYAXIAL SCREW, CC, 6.5mm X 45mm; Item Number: TL1-10765045.    10. POLYAXIAL SCREW, CC, 6.5mm X 50mm; Item Number: TL1-10765050.    11. POLYAXIAL SCREW, CC, 6.5mm X 55mm; Item Number: TL1-10765055.    12. POLYAXIAL SCREW, CC, 6.5mm X 60mm; Item Number: TL1-10765060.    13. POLYAXIAL SCREW, CC, 7.5mm X 30mm; Item Number: TL1-10775030.    14. POLYAXIAL SCREW, CC, 7.5mm X 35mm; Item Number: TL1-10775035.    15. POLYAXIAL SCREW, CC, 7.5mm X 40mm; Item Number: TL1-10775040.    16. POLYAXIAL SCREW, CC, 7.5mm X 45mm; Item Number: TL1-10775045.    17. POLYAXIAL SCREW, CC, 7.5mm X 50mm; Item Number: TL1-10775050.    18. POLYAXIAL SCREW, CC, 7.5mm X 55mm; Item Number: TL1-10775055.    19. POLYAXIAL SCREW, CC, 7.5mm X 60mm; Item Number: TL1-10775060.    20. POLYAXIAL SCREW, CC, 8.5mm X 35mm; Item Number: TL1-10785035.    21. POLYAXIAL SCREW, CC, 8.5mm X 40mm; Item Number: TL1-10785040.    22. POLYAXIAL SCREW, CC, 8.5mm X 45mm; Item Number: TL1-10785045.    23. POLYAXIAL SCREW, CC, 8.5mm X 50mm; Item Number: TL1-10785050.    24. POLYAXIAL SCREW, CC, 8.5mm X 55mm; Item Number: TL1-10785055.    25. POLYAXIAL SCREW, CC, 8.5mm X 60mm; Item Number: TL1-10785060.",
  "description": "FDA recall Z-0478-2026 — Orthofix U.S. LLC is recalling Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:     1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030.    2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035.    3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040.    4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045.    5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050.    6. POLYAXIAL SCREW, CC, 6.5mm X 30mm; Item Number: TL1-10765030.    7. POLYAXIAL SCREW, CC, 6.5mm X 35mm; Item Number: TL1-10765035.    8. POLYAXIAL SCREW, CC, 6.5mm X 40mm; Item Number: TL1-10765040.    9. POLYAXIAL SCREW, CC, 6.5mm X 45mm; Item Number: TL1-10765045.    10. POLYAXIAL SCREW, CC, 6.5mm X 50mm; Item Number: TL1-10765050.    11. POLYAXIAL SCREW, CC, 6.5mm X 55mm; Item Number: TL1-10765055.    12. POLYAXIAL SCREW, CC, 6.5mm X 60mm; Item Number: TL1-10765060.    13. POLYAXIAL SCREW, CC, 7.5mm X 30mm; Item Number: TL1-10775030.    14. POLYAXIAL SCREW, CC, 7.5mm X 35mm; Item Number: TL1-10775035.    15. POLYAXIAL SCREW, CC, 7.5mm X 40mm; Item Number: TL1-10775040.    16. POLYAXIAL SCREW, CC, 7.5mm X 45mm; Item Number: TL1-10775045.    17. POLYAXIAL SCREW, CC, 7.5mm X 50mm; Item Number: TL1-10775050.    18. POLYAXIAL SCREW, CC, 7.5mm X 55mm; Item Number: TL1-10775055.    19. POLYAXIAL SCREW, CC, 7.5mm X 60mm; Item Number: TL1-10775060.    20. POLYAXIAL SCREW, CC, 8.5mm X 35mm; Item Number: TL1-10785035.    21. POLYAXIAL SCREW, CC, 8.5mm X 40mm; Item Number: TL1-10785040.    22. POLYAXIAL SCREW, CC, 8.5mm X 45mm; Item Number: TL1-10785045.    23. POLYAXIAL SCREW, CC, 8.5mm X 50mm; Item Number: TL1-10785050.    24. POLYAXIAL SCREW, CC, 8.5mm X 55mm; Item Number: TL1-10785055.    25. POLYAXIAL SCREW, CC, 8.5mm X 60mm; Item Number: TL1-10785060. (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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    "name": "Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:     1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030.    2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035.    3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040.    4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045.    5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050.    6. POLYAXIAL SCREW, CC, 6.5mm X 30mm; Item Number: TL1-10765030.    7. POLYAXIAL SCREW, CC, 6.5mm X 35mm; Item Number: TL1-10765035.    8. POLYAXIAL SCREW, CC, 6.5mm X 40mm; Item Number: TL1-10765040.    9. POLYAXIAL SCREW, CC, 6.5mm X 45mm; Item Number: TL1-10765045.    10. POLYAXIAL SCREW, CC, 6.5mm X 50mm; Item Number: TL1-10765050.    11. POLYAXIAL SCREW, CC, 6.5mm X 55mm; Item Number: TL1-10765055.    12. POLYAXIAL SCREW, CC, 6.5mm X 60mm; Item Number: TL1-10765060.    13. POLYAXIAL SCREW, CC, 7.5mm X 30mm; Item Number: TL1-10775030.    14. POLYAXIAL SCREW, CC, 7.5mm X 35mm; Item Number: TL1-10775035.    15. POLYAXIAL SCREW, CC, 7.5mm X 40mm; Item Number: TL1-10775040.    16. POLYAXIAL SCREW, CC, 7.5mm X 45mm; Item Number: TL1-10775045.    17. POLYAXIAL SCREW, CC, 7.5mm X 50mm; Item Number: TL1-10775050.    18. POLYAXIAL SCREW, CC, 7.5mm X 55mm; Item Number: TL1-10775055.    19. POLYAXIAL SCREW, CC, 7.5mm X 60mm; Item Number: TL1-10775060.    20. POLYAXIAL SCREW, CC, 8.5mm X 35mm; Item Number: TL1-10785035.    21. POLYAXIAL SCREW, CC, 8.5mm X 40mm; Item Number: TL1-10785040.    22. POLYAXIAL SCREW, CC, 8.5mm X 45mm; Item Number: TL1-10785045.    23. POLYAXIAL SCREW, CC, 8.5mm X 50mm; Item Number: TL1-10785050.    24. POLYAXIAL SCREW, CC, 8.5mm X 55mm; Item Number: TL1-10785055.    25. POLYAXIAL SCREW, CC, 8.5mm X 60mm; Item Number: TL1-10785060.",
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      "name": "FDA recall Z-0478-2026: Orthofix U.S. LLC is recalling Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:     1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030.    2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035.    3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040.    4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045.    5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050.    6. POLYAXIAL SCREW, CC, 6.5mm X 30mm; Item Number: TL1-10765030.    7. POLYAXIAL SCREW, CC, 6.5mm X 35mm; Item Number: TL1-10765035.    8. POLYAXIAL SCREW, CC, 6.5mm X 40mm; Item Number: TL1-10765040.    9. POLYAXIAL SCREW, CC, 6.5mm X 45mm; Item Number: TL1-10765045.    10. POLYAXIAL SCREW, CC, 6.5mm X 50mm; Item Number: TL1-10765050.    11. POLYAXIAL SCREW, CC, 6.5mm X 55mm; Item Number: TL1-10765055.    12. POLYAXIAL SCREW, CC, 6.5mm X 60mm; Item Number: TL1-10765060.    13. POLYAXIAL SCREW, CC, 7.5mm X 30mm; Item Number: TL1-10775030.    14. POLYAXIAL SCREW, CC, 7.5mm X 35mm; Item Number: TL1-10775035.    15. POLYAXIAL SCREW, CC, 7.5mm X 40mm; Item Number: TL1-10775040.    16. POLYAXIAL SCREW, CC, 7.5mm X 45mm; Item Number: TL1-10775045.    17. POLYAXIAL SCREW, CC, 7.5mm X 50mm; Item Number: TL1-10775050.    18. POLYAXIAL SCREW, CC, 7.5mm X 55mm; Item Number: TL1-10775055.    19. POLYAXIAL SCREW, CC, 7.5mm X 60mm; Item Number: TL1-10775060.    20. POLYAXIAL SCREW, CC, 8.5mm X 35mm; Item Number: TL1-10785035.    21. POLYAXIAL SCREW, CC, 8.5mm X 40mm; Item Number: TL1-10785040.    22. POLYAXIAL SCREW, CC, 8.5mm X 45mm; Item Number: TL1-10785045.    23. POLYAXIAL SCREW, CC, 8.5mm X 50mm; Item Number: TL1-10785050.    24. POLYAXIAL SCREW, CC, 8.5mm X 55mm; Item Number: TL1-10785055.    25. POLYAXIAL SCREW, CC, 8.5mm X 60mm; Item Number: TL1-10785060.",
      "text": "The FDA logged enforcement record Z-0478-2026: Orthofix U.S. LLC is voluntarily recalling Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:     1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030.    2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035.    3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040.    4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045.    5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050.    6. POLYAXIAL SCREW, CC, 6.5mm X 30mm; Item Number: TL1-10765030.    7. POLYAXIAL SCREW, CC, 6.5mm X 35mm; Item Number: TL1-10765035.    8. POLYAXIAL SCREW, CC, 6.5mm X 40mm; Item Number: TL1-10765040.    9. POLYAXIAL SCREW, CC, 6.5mm X 45mm; Item Number: TL1-10765045.    10. POLYAXIAL SCREW, CC, 6.5mm X 50mm; Item Number: TL1-10765050.    11. POLYAXIAL SCREW, CC, 6.5mm X 55mm; Item Number: TL1-10765055.    12. POLYAXIAL SCREW, CC, 6.5mm X 60mm; Item Number: TL1-10765060.    13. POLYAXIAL SCREW, CC, 7.5mm X 30mm; Item Number: TL1-10775030.    14. POLYAXIAL SCREW, CC, 7.5mm X 35mm; Item Number: TL1-10775035.    15. POLYAXIAL SCREW, CC, 7.5mm X 40mm; Item Number: TL1-10775040.    16. POLYAXIAL SCREW, CC, 7.5mm X 45mm; Item Number: TL1-10775045.    17. POLYAXIAL SCREW, CC, 7.5mm X 50mm; Item Number: TL1-10775050.    18. POLYAXIAL SCREW, CC, 7.5mm X 55mm; Item Number: TL1-10775055.    19. POLYAXIAL SCREW, CC, 7.5mm X 60mm; Item Number: TL1-10775060.    20. POLYAXIAL SCREW, CC, 8.5mm X 35mm; Item Number: TL1-10785035.    21. POLYAXIAL SCREW, CC, 8.5mm X 40mm; Item Number: TL1-10785040.    22. POLYAXIAL SCREW, CC, 8.5mm X 45mm; Item Number: TL1-10785045.    23. POLYAXIAL SCREW, CC, 8.5mm X 50mm; Item Number: TL1-10785050.    24. POLYAXIAL SCREW, CC, 8.5mm X 55mm; Item Number: TL1-10785055.    25. POLYAXIAL SCREW, CC, 8.5mm X 60mm; Item Number: TL1-10785060. — reason: Polyaxial screws do not meet performance standards.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-19. Affected lots/codes: 1. Item Number: TL1-10755030. UDI-DI: 10889981335229. Lot Number: JP2572B.  2. Item Number: TL1-10755035. UDI-DI: 10889981336165. Lot Number: JP2757B.  3. Item Number: TL1-10755040. UDI-DI: 10889981335717. Lot Number: JP2758B.  4. Item Number: TL1-10755045. UDI-DI: 10889981335953. Lot Numbers: JP2759B, JP2799B, JP2800B, JP2880B.  5. Item Number: TL1-10755050. UDI-DI: 10889981336318. Lot Numbers: JP2760B, JP2801B.  6. Item Number: TL1-10765030. UDI-DI: 10889981335885. Lot Number: JP2655B.  7. Item Number: TL1-10765035. UDI-DI: 10889981335540. Lot Number: JP2656B.  8. Item Number: TL1-10765040. UDI-DI: 10889981336332. Lot Number: JP2657B, JP2791B.  9. Item Number: TL1-10765045. UDI-DI: 10889981335526. Lot Numbers: JP2658B, JP2659B, JP2792B.  10. Item Number: TL1-10765050. UDI-DI: 10889981335342. Lot Numbers: JP2660B, JP2794B, JP2795B.  11. Item Number: TL1-10765055. UDI-DI: 10889981335168. Lot Number: JP2661B.  12. Item Number: . UDI-DI: . Lot Number: Item Number: TL1-10765060. UDI-DI: 10889981335816. Lot Number: JP2662B.  13. Item Number: TL1-10775030. UDI-DI: 10889981335427. Lot Number: JP2663B.  14. Item Number: TL1-10775035. UDI-DI: 10889981335632. Lot Number: JP2668B.  15. Item Number: TL1-10775040. UDI-DI: 10889981335113. Lot Number: JP2669B.  16. Item Number: TL1-10775045. UDI-DI: 10889981335403. Lot Number: JP2670B.  17. Item Number: TL1-10775050. UDI-DI: 10889981335830. Lot Number: JP2671B.  18. Item Number: TL1-10775055. UDI-DI: 10889981335250. Lot Numbers: JP2672B, JP2887B.  19. Item Number: TL1-10775060. UDI-DI: 10889981335076. Lot Number: JP2673B.  20. Item Number: TL1-10785035. UDI-DI: 10889981335410. Lot Number: JP2674B.  21. Item Number: TL1-10785040. UDI-DI: 10889981335779. Lot Number: JP2675B.  22. Item Number: TL1-10785045. UDI-DI: 10889981335243. Lot Number: JP2664B.  23. Item Number: TL1-10785050. UDI-DI: 10889981335847. Lot Number: JP2665B.  24. Item Number: TL1-10785055. UDI-DI: 10889981335106. Lot Number: JP2666B.  25. Item Number: TL1-10785060. UDI-DI: 10889981334949. Lot Number: JP2667B.. A RECORDED FDA enforcement action (occurred=true).",
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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-0478-2026 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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      "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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0478-2026/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,
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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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          "item": {
            "Field": "Lot/code info",
            "Value": "1. Item Number: TL1-10755030. UDI-DI: 10889981335229. Lot Number: JP2572B.  2. Item Number: TL1-10755035. UDI-DI: 10889981336165. Lot Number: JP2757B.  3. Item Number: TL1-10755040. UDI-DI: 10889981335717. Lot Number: JP2758B.  4. Item Number: TL1-10755045. UDI-DI: 10889981335953. Lot Numbers: JP2759B, JP2799B, JP2800B, JP2880B.  5. Item Number: TL1-10755050. UDI-DI: 10889981336318. Lot Numbers: JP2760B, JP2801B.  6. Item Number: TL1-10765030. UDI-DI: 10889981335885. Lot Number: JP2655B.  7. Item Number: TL1-10765035. UDI-DI: 10889981335540. Lot Number: JP2656B.  8. Item Number: TL1-10765040. UDI-DI: 10889981336332. Lot Number: JP2657B, JP2791B.  9. Item Number: TL1-10765045. UDI-DI: 10889981335526. Lot Numbers: JP2658B, JP2659B, JP2792B.  10. Item Number: TL1-10765050. UDI-DI: 10889981335342. Lot Numbers: JP2660B, JP2794B, JP2795B.  11. Item Number: TL1-10765055. UDI-DI: 10889981335168. Lot Number: JP2661B.  12. Item Number: . UDI-DI: . Lot Number: Item Number: TL1-10765060. UDI-DI: 10889981335816. Lot Number: JP2662B.  13. Item Number: TL1-10775030. UDI-DI: 10889981335427. Lot Number: JP2663B.  14. Item Number: TL1-10775035. UDI-DI: 10889981335632. Lot Number: JP2668B.  15. Item Number: TL1-10775040. UDI-DI: 10889981335113. Lot Number: JP2669B.  16. Item Number: TL1-10775045. UDI-DI: 10889981335403. Lot Number: JP2670B.  17. Item Number: TL1-10775050. UDI-DI: 10889981335830. Lot Number: JP2671B.  18. Item Number: TL1-10775055. UDI-DI: 10889981335250. Lot Numbers: JP2672B, JP2887B.  19. Item Number: TL1-10775060. UDI-DI: 10889981335076. Lot Number: JP2673B.  20. Item Number: TL1-10785035. UDI-DI: 10889981335410. Lot Number: JP2674B.  21. Item Number: TL1-10785040. UDI-DI: 10889981335779. Lot Number: JP2675B.  22. Item Number: TL1-10785045. UDI-DI: 10889981335243. Lot Number: JP2664B.  23. Item Number: TL1-10785050. UDI-DI: 10889981335847. Lot Number: JP2665B.  24. Item Number: TL1-10785055. UDI-DI: 10889981335106. Lot Number: JP2666B.  25. Item Number: TL1-10785060. UDI-DI: 10889981334949. Lot Number: JP2667B.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of California, North Carolina, and Texas.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}