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  "@type": "schema:Dataset",
  "name": "Brand Name: CONSTRUX\" Mini Ti Spacer System  Product Name: CONSTRUX\" Mini Ti Spacer System  Model/Catalog Number: 37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic",
  "description": "FDA recall Z-0896-2026 — Orthofix U.S. LLC is recalling Brand Name: CONSTRUX\" Mini Ti Spacer System  Product Name: CONSTRUX\" Mini Ti Spacer System  Model/Catalog Number: 37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic (Devices, Class III). 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": "Brand Name: CONSTRUX\" Mini Ti Spacer System  Product Name: CONSTRUX\" Mini Ti Spacer System  Model/Catalog Number: 37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Orthofix U.S. LLC"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0896-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0896-2026: Orthofix U.S. LLC is recalling Brand Name: CONSTRUX\" Mini Ti Spacer System  Product Name: CONSTRUX\" Mini Ti Spacer System  Model/Catalog Number: 37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic",
      "text": "The FDA logged enforcement record Z-0896-2026: Orthofix U.S. LLC is voluntarily recalling Brand Name: CONSTRUX\" Mini Ti Spacer System  Product Name: CONSTRUX\" Mini Ti Spacer System  Model/Catalog Number: 37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6005SP\t12mm W  X 12mm L, 5mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6006SP\t12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6007SP\t12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6008SP\t12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6009SP\t12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6010SP\t12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6011SP\t12mm W  X 12mm L, 11mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6012SP\t12mm W  X 12mm L, 12mm H, 5¿ Lordotic  37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6105SP\t12mm W X 12mm L, 5mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6106SP\t12mm W X 12mm L 6mm H, Parallel   37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6107SP\t12mm W X 12mm L, 7mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6108SP\t12mm W X 12mm L, 8mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6109SP\t12mm W X 12mm L, 9mm H, Parallel  37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6110SP\t12mm W X 12mm L, 10mm H, Parallel   37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6111SP\t12mm W X 12mm L, 11mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6112SP\t12mm W X 12mm L, 12mm H, Parallel  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6206SP\t12mm W X 12mm L, 6mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic  37-6211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic — reason: Labeling contains claims that are not consistently  present.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-11-03. Affected lots/codes: Lot Code: All Lot Codes/ UDI: 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6008SP 18257200150182 37-6008SP 18257200150182 37-6008SP 18257200150182 37-6009SP 18257200150199 37-6009SP 18257200150199 37-6009SP 18257200150199 37-6010SP 18257200150205 37-6010SP 18257200150205 37-6010SP 18257200150205 37-6011SP 18257200150212 37-6011SP 18257200150212 37-6011SP 18257200150212 37-6012SP 18257200150229 37-6012SP 18257200150229 37-6012SP 18257200150229 37-6105SP 18257200149759 37-6105SP 18257200149759 37-6105SP 18257200149759 37-6106SP 18257200149766 37-6106SP 18257200149766 37-6106SP 18257200149766 37-6107SP 18257200149773 37-6107SP 18257200149773 37-6107SP 18257200149773 37-6108SP 18257200149780 37-6108SP 18257200149780 37-6108SP 18257200149780 37-6109SP 18257200149797 37-6109SP 18257200149797 37-6109SP 18257200149797 37-6110SP 18257200149803 37-6110SP 18257200149803 37-6110SP 18257200149803 37-6111SP 18257200149810 37-6111SP 18257200149810 37-6111SP 18257200149810 37-6112SP 18257200149827 37-6112SP 18257200149827 37-6112SP 18257200149827 37-6206SP 18257200150557 37-6206SP 18257200150557 37-6206SP 18257200150557 37-6207SP 18257200150564 37-6207SP 18257200150564 37-6207SP 18257200150564 37-6208SP 18257200150571 37-6208SP 18257200150571 37-6208SP 18257200150571 37-6209SP 18257200150588 37-6209SP 18257200150588 37-6209SP 18257200150588 37-6210SP 18257200150595 37-6210SP 18257200150595 37-6210SP 18257200150595 37-6211SP 18257200150601 37-6211SP 18257200150601 37-6211SP 18257200150601 37-6212SP 18257200150618 37-6212SP 18257200150618 37-6212SP 18257200150618 37-6306SP 18257200150915 37-6306SP 18257200150915 37-6306SP 18257200150915 37-6307SP 18257200150922 37-6307SP 18257200150922 37-6307SP 18257200150922 37-6308SP 18257200150939 37-6308SP 18257200150939 37-6308SP 18257200150939 37-6309SP 18257200150946 37-6309SP 18257200150946 37-6309SP 18257200150946 37-6310SP 18257200150953 37-6310SP 18257200150953 37-6310SP 18257200150953 37-6311SP 18257200150960 37-6311SP 18257200150960 37-6311SP 18257200150960 37-6312SP 18257200150977 37-6312SP 18257200150977 37-6312SP 18257200150977 37-7005SP 18257200150250 37-7005SP 18257200150250 37-7005SP 18257200150250 37-7006SP 18257200150267 37-7006SP 18257200150267 37-7006SP 18257200150267 37-7007SP 18257200150274 37-7007SP 18257200150274 37-7007SP 18257200150274 37-7008SP 18257200150281 37-7008SP 18257200150281 37-7008SP 18257200150281 37-7009SP 18257200150298 37-7009SP 18257200150298 37-7009SP 18257200150298 37-7010SP 18257200150304 37-7010SP 18257200150304 37-7010SP 18257200150304 37-7011SP 18257200150311 37-7011SP 18257200150311 37-7011SP 18257200150311 37-7012SP 18257200150328 37-7012SP 18257200150328 37-7012SP 18257200150328 37-7105SP 18257200149858 37-7105SP 18257200149858 37-7105SP 18257200149858 37-7106SP 18257200149865 37-7106SP 18257200149865 37-7106SP 18257200149865 37-7107SP 18257200149872 37-7107SP 18257200149872 37-7107SP 18257200149872 37-7108SP 18257200149889 37-7108SP 18257200149889 37-7108SP 18257200149889 37-7109SP 18257200149896 37-7109SP 18257200149896 37-7109SP 18257200149896 37-7110SP 18257200149902 37-7110SP 18257200149902 37-7110SP 18257200149902 37-7111SP 18257200149919 37-7111SP 18257200149919 37-7111SP 18257200149919 37-7112SP 18257200149926 37-7112SP 18257200149926 37-7112SP 18257200149926 37-7206SP 18257200150649 37-7206SP 18257200150649 37-7206SP 18257200150649 37-7207SP 18257200150656 37-7207SP 18257200150656 37-7207SP 18257200150656 37-7208SP 18257200150663 37-7208SP 18257200150663 37-7208SP 18257200150663 37-7209SP 18257200150670 37-7209SP 18257200150670 37-7209SP 18257200150670 37-7210SP 18257200150687 37-7210SP 18257200150687 37-7210SP 18257200150687 37-7211SP 18257200150694 37-7211SP 18257200150694 37-7211SP 18257200150694 37-7212SP 18257200150700 37-7212SP 18257200150700 37-7212SP 18257200150700 37-7306SP 18257200151004 37-7306SP 18257200151004 37-7306SP 18257200151004 37-7307SP 18257200151011 37-7307SP 18257200151011 37-7307SP 18257200151011 37-7308SP 18257200151028 37-7308SP 18257200151028 37-7308SP 18257200151028 37-7309SP 18257200151035 37-7309SP 18257200151035 37-7309SP 18257200151035 37-7310SP 18257200151042 37-7310SP 18257200151042 37-7310SP 18257200151042 37-7311SP 18257200151059 37-7311SP 18257200151059 37-7311SP 18257200151059 37-7312SP 18257200151066 37-7312SP 18257200151066 37-7312SP 18257200151066 37-8005SP 18257200150359 37-8005SP 18257200150359 37-8005SP 18257200150359 37-8006SP 18257200150366 37-8006SP 18257200150366 37-8006SP 18257200150366 37-8007SP 18257200150373 37-8007SP 18257200150373 37-8007SP 18257200150373 37-8008SP 18257200150380 37-8008SP 18257200150380 37-8008SP 18257200150380 37-8009SP 18257200150397 37-8009SP 18257200150397 37-8009SP 18257200150397 37-8011SP 18257200150410 37-8011SP 18257200150410 37-8011SP 18257200150410 37-8012SP 18257200150427 37-8012SP 18257200150427 37-8012SP 18257200150427 37-8015SP 18257200150403 37-8015SP 18257200150403 37-8015SP 18257200150403 37-8105SP 18257200149957 37-8105SP 18257200149957 37-8105SP 18257200149957 37-8106SP 18257200149964 37-8106SP 18257200149964 37-8106SP 18257200149964 37-8107SP 18257200149971 37-8107SP 18257200149971 37-8107SP 18257200149971 37-8108SP 18257200149988 37-8108SP 18257200149988 37-8108SP 18257200149988 37-8109SP 18257200149995 37-8109SP 18257200149995 37-8109SP 18257200149995 37-8110SP 18257200150007 37-8110SP 18257200150007 37-8110SP 18257200150007 37-8111SP 18257200150014 37-8111SP 18257200150014 37-8111SP 18257200150014 37-8112SP 18257200150021 37-8112SP 18257200150021 37-8112SP 18257200150021 37-8206SP 18257200150731 37-8206SP 18257200150731 37-8206SP 18257200150731 37-8207SP 18257200150748 37-8207SP 18257200150748 37-8207SP 18257200150748 37-8208SP 18257200150755 37-8208SP 18257200150755 37-8208SP 18257200150755 37-8209SP 18257200150762 37-8209SP 18257200150762 37-8209SP 18257200150762 37-8210SP 18257200150779 37-8210SP 18257200150779 37-8210SP 18257200150779 37-8211SP 18257200150786 37-8211SP 18257200150786 37-8211SP 18257200150786 37-8212SP 18257200150793 37-8212SP 18257200150793 37-8212SP 18257200150793 37-8306SP 18257200151097 37-8306SP 18257200151097 37-8306SP 18257200151097 37-8307SP 18257200151103 37-8307SP 18257200151103 37-8307SP 18257200151103 37-8308SP 18257200151110 37-8308SP 18257200151110 37-8308SP 18257200151110 37-8309SP 18257200151127 37-8309SP 18257200151127 37-8309SP 18257200151127 37-8310SP 18257200151134 37-8310SP 18257200151134 37-8310SP 18257200151134 37-8311SP 18257200151141 37-8311SP 18257200151141 37-8311SP 18257200151141 37-8312SP 18257200151158 37-8312SP 18257200151158 37-8312SP 18257200151158 37-9005SP 18257200150458 37-9005SP 18257200150458 37-9005SP 18257200150458 37-9006SP 18257200150465 37-9006SP 18257200150465 37-9006SP 18257200150465 37-9007SP 18257200150472 37-9007SP 18257200150472 37-9007SP 18257200150472 37-9008SP 18257200150489 37-9008SP 18257200150489 37-9008SP 18257200150489 37-9009SP 18257200150496 37-9009SP 18257200150496 37-9009SP 18257200150496 37-9011SP 18257200150519 37-9011SP 18257200150519 37-9011SP 18257200150519 37-9012SP 18257200150526 37-9012SP 18257200150526 37-9105SP 18257200150052 37-9105SP 18257200150052 37-9106SP 18257200150069 37-9106SP 18257200150069 37-9107SP 18257200150076 37-9107SP 18257200150076 37-9108SP 18257200150083 37-9108SP 18257200150083 37-9109SP 18257200150090 37-9109SP 18257200150090 37-9110SP 18257200150106 37-9110SP 18257200150106 37-9111SP 18257200150113 37-9111SP 18257200150113 37-9112SP 18257200150120 37-9112SP 18257200150120 37-9206SP 18257200150823 37-9206SP 18257200150823 37-9207SP 18257200150830 37-9207SP 18257200150830 37-9208SP 18257200150847 37-9208SP 18257200150847 37-9209SP 18257200150854 37-9209SP 18257200150854 37-9210SP 18257200150861 37-9210SP 18257200150861 37-9211SP 18257200150878 37-9211SP 18257200150878 37-9212SP 18257200150885 37-9212SP 18257200150885 37-9306SP 18257200151189 37-9306SP 18257200151189 37-9307SP 18257200151196 37-9307SP 18257200151196 37-9308SP 18257200151202 37-9308SP 18257200151202 37-9309SP 18257200151219 37-9309SP 18257200151219 37-9310SP 18257200151226 37-9310SP 18257200151226 37-9311SP 18257200151233 37-9311SP 18257200151233 37-9312SP 18257200151240 37-9312SP 18257200151240. 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-0896-2026&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-0896-2026&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-0896-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0896-2026 as Class III",
      "text": "The FDA assigned this recall Class III: Class III — the FDA judged the product is unlikely to cause 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-0896-2026&lang=eng",
        "value": "Class III",
        "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-0896-2026&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-0896-2026/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": {
        "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."
    }
  ],
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}