{
  "@context": {
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    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
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    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0895-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Brand Name: Forza\" Ti Spacer System  Product Name: Forza\" Ti Spacer System  Model/Catalog Number: 38-2006SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H;  38-2007SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H;  38-2008SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H;  38-2009SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H;  38-2010SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H;  38-2011SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H;  38-2012SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H;  38-2013SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H;  38-2014SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H;  38-2106SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H;  38-2107SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H;  38-2108SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H;  38-2109SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H;  38-2110SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H;  38-2111SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H;  38-2112SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H;  38-2113SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H;  38-2114SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H;  38-2206SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H;  38-2207SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H;  38-2208SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H;  38-2209SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H;  38-2210SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H;  38-2211SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H;  38-2212SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H;  38-2213SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H;  38-2214SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H;  38-2309SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H;  38-2310SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H;  38-2311SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H;  38-2312SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H;  38-2313SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H;  38-2314SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H;  38-2508SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H;  38-2509SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H;  38-2510SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H;  38-2511SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H;  38-2512SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H;  38-2513SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H;  38-2514SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H;  38-3206SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H;  38-3207SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H;  38-3208SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H;  38-3209SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H;  38-3210SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H;  38-3211SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H;  38-3212SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H;  38-3213SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H;  38-3214SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H;  38-3409SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H;  38-3410SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H;  38-3411SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H;  38-3412SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H;",
  "description": "FDA recall Z-0895-2026 — Orthofix U.S. LLC is recalling Brand Name: Forza\" Ti Spacer System  Product Name: Forza\" Ti Spacer System  Model/Catalog Number: 38-2006SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H;  38-2007SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H;  38-2008SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H;  38-2009SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H;  38-2010SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H;  38-2011SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H;  38-2012SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H;  38-2013SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H;  38-2014SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H;  38-2106SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H;  38-2107SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H;  38-2108SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H;  38-2109SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H;  38-2110SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H;  38-2111SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H;  38-2112SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H;  38-2113SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H;  38-2114SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H;  38-2206SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H;  38-2207SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H;  38-2208SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H;  38-2209SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H;  38-2210SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H;  38-2211SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H;  38-2212SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H;  38-2213SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H;  38-2214SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H;  38-2309SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H;  38-2310SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H;  38-2311SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H;  38-2312SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H;  38-2313SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H;  38-2314SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H;  38-2508SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H;  38-2509SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H;  38-2510SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H;  38-2511SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H;  38-2512SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H;  38-2513SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H;  38-2514SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H;  38-3206SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H;  38-3207SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H;  38-3208SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H;  38-3209SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H;  38-3210SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H;  38-3211SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H;  38-3212SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H;  38-3213SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H;  38-3214SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H;  38-3409SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H;  38-3410SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H;  38-3411SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H;  38-3412SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H; (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.",
  "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-0895-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Forza\" Ti Spacer System  Product Name: Forza\" Ti Spacer System  Model/Catalog Number: 38-2006SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H;  38-2007SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H;  38-2008SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H;  38-2009SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H;  38-2010SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H;  38-2011SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H;  38-2012SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H;  38-2013SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H;  38-2014SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H;  38-2106SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H;  38-2107SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H;  38-2108SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H;  38-2109SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H;  38-2110SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H;  38-2111SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H;  38-2112SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H;  38-2113SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H;  38-2114SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H;  38-2206SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H;  38-2207SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H;  38-2208SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H;  38-2209SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H;  38-2210SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H;  38-2211SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H;  38-2212SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H;  38-2213SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H;  38-2214SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H;  38-2309SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H;  38-2310SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H;  38-2311SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H;  38-2312SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H;  38-2313SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H;  38-2314SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H;  38-2508SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H;  38-2509SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H;  38-2510SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H;  38-2511SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H;  38-2512SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H;  38-2513SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H;  38-2514SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H;  38-3206SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H;  38-3207SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H;  38-3208SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H;  38-3209SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H;  38-3210SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H;  38-3211SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H;  38-3212SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H;  38-3213SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H;  38-3214SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H;  38-3409SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H;  38-3410SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H;  38-3411SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H;  38-3412SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Orthofix U.S. LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0895-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0895-2026: Orthofix U.S. LLC is recalling Brand Name: Forza\" Ti Spacer System  Product Name: Forza\" Ti Spacer System  Model/Catalog Number: 38-2006SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H;  38-2007SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H;  38-2008SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H;  38-2009SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H;  38-2010SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H;  38-2011SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H;  38-2012SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H;  38-2013SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H;  38-2014SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H;  38-2106SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H;  38-2107SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H;  38-2108SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H;  38-2109SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H;  38-2110SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H;  38-2111SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H;  38-2112SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H;  38-2113SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H;  38-2114SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H;  38-2206SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H;  38-2207SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H;  38-2208SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H;  38-2209SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H;  38-2210SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H;  38-2211SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H;  38-2212SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H;  38-2213SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H;  38-2214SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H;  38-2309SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H;  38-2310SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H;  38-2311SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H;  38-2312SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H;  38-2313SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H;  38-2314SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H;  38-2508SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H;  38-2509SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H;  38-2510SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H;  38-2511SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H;  38-2512SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H;  38-2513SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H;  38-2514SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H;  38-3206SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H;  38-3207SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H;  38-3208SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H;  38-3209SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H;  38-3210SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H;  38-3211SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H;  38-3212SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H;  38-3213SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H;  38-3214SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H;  38-3409SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H;  38-3410SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H;  38-3411SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H;  38-3412SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H;",
      "text": "The FDA logged enforcement record Z-0895-2026: Orthofix U.S. LLC is voluntarily recalling Brand Name: Forza\" Ti Spacer System  Product Name: Forza\" Ti Spacer System  Model/Catalog Number: 38-2006SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H;  38-2007SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H;  38-2008SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H;  38-2009SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H;  38-2010SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H;  38-2011SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H;  38-2012SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H;  38-2013SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H;  38-2014SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H;  38-2106SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H;  38-2107SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H;  38-2108SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H;  38-2109SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H;  38-2110SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H;  38-2111SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H;  38-2112SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H;  38-2113SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H;  38-2114SP\tFORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H;  38-2206SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H;  38-2207SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H;  38-2208SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H;  38-2209SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H;  38-2210SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H;  38-2211SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H;  38-2212SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H;  38-2213SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H;  38-2214SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H;  38-2309SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H;  38-2310SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H;  38-2311SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H;  38-2312SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H;  38-2313SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H;  38-2314SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H;  38-2508SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H;  38-2509SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H;  38-2510SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H;  38-2511SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H;  38-2512SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H;  38-2513SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H;  38-2514SP\tFORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H;  38-3206SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H;  38-3207SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H;  38-3208SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H;  38-3209SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H;  38-3210SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H;  38-3211SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H;  38-3212SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H;  38-3213SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H;  38-3214SP\tFORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H;  38-3409SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H;  38-3410SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H;  38-3411SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H;  38-3412SP\tFORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H; — 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: 38-2006SP 18257200151769 38-2007SP 18257200151776 38-2008SP 18257200151783 38-2009SP 18257200151790 38-2010SP 18257200151806 38-2011SP 18257200151813 38-2012SP 18257200151820 38-2013SP 18257200151837 38-2014SP 18257200151844 38-2106SP 18257200151875 38-2107SP 18257200151882 38-2108SP 18257200151899 38-2109SP 18257200151905 38-2110SP 18257200151912 38-2111SP 18257200151929 38-2112SP 18257200151936 38-2113SP 18257200151943 38-2114SP 18257200151950 38-2206SP 18257200151981 38-2207SP 18257200151998 38-2208SP 18257200152001 38-2209SP 18257200152018 38-2210SP 18257200152025 38-2211SP 18257200152032 38-2212SP 18257200152049 38-2213SP 18257200152056 38-2214SP 18257200152063 38-2309SP 18257200152094 38-2310SP 18257200152100 38-2311SP 18257200152117 38-2312SP 18257200152124 38-2313SP 18257200152131 38-2314SP 18257200152148 38-2508SP 18257200152360 38-2509SP 18257200152377 38-2510SP 18257200152384 38-2511SP 18257200152391 38-2512SP 18257200152407 38-2513SP 18257200152414 38-2514SP 18257200152421 38-3206SP 18257200152179 38-3207SP 18257200152186 38-3208SP 18257200152193 38-3209SP 18257200152209 38-3210SP 18257200152216 38-3211SP 18257200152223 38-3212SP 18257200152230 38-3213SP 18257200152247 38-3214SP 18257200152254 38-3409SP 18257200152285 38-3410SP 18257200152292 38-3411SP 18257200152308 38-3412SP 18257200152315 38-3413SP 18257200152322 38-3414SP 18257200152339 38-3506SP 18257200152759 38-3507SP 18257200152766 38-3508SP 18257200152773 38-3509SP 18257200152780 38-3510SP 18257200152797 38-3511SP 18257200152803 38-3512SP 18257200152810 38-3513SP 18257200152827 38-3514SP 18257200152834 38-3608SP 18257200152865 38-3609SP 18257200152872 38-3610SP 18257200152889 38-3611SP 18257200152896 38-3612SP 18257200152902 38-3613SP 18257200152919 38-3614SP 18257200152926 38-3706SP 18257200152957 38-3707SP 18257200152964 38-3708SP 18257200152971 38-3709SP 18257200152988 38-3710SP 18257200152995 38-3711SP 18257200153008 38-3712SP 18257200153015 38-3713SP 18257200153022 38-3714SP 18257200153039 38-3808SP 18257200153060 38-3809SP 18257200153077 38-3810SP 18257200153084 38-3811SP 18257200153091 38-3812SP 18257200153107 38-3813SP 18257200153114 38-3814SP 18257200153121 38-3908SP 18257200153152 38-3909SP 18257200153169 38-3910SP 18257200153176 38-3911SP 18257200153183 38-3912SP 18257200153190 38-3913SP 18257200153206 38-3914SP 18257200153213. 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-0895-2026&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-0895-2026&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-0895-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0895-2026 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-0895-2026&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-0895-2026&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-0895-2026/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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0895-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0895-2026",
            "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 III",
            "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": "Orthofix U.S. LLC",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Labeling contains claims that are not consistently  present.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-11-03",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Lot Code: All Lot Codes/ UDI: 38-2006SP 18257200151769 38-2007SP 18257200151776 38-2008SP 18257200151783 38-2009SP 18257200151790 38-2010SP 18257200151806 38-2011SP 18257200151813 38-2012SP 18257200151820 38-2013SP 18257200151837 38-2014SP 18257200151844 38-2106SP 18257200151875 38-2107SP 18257200151882 38-2108SP 18257200151899 38-2109SP 18257200151905 38-2110SP 18257200151912 38-2111SP 18257200151929 38-2112SP 18257200151936 38-2113SP 18257200151943 38-2114SP 18257200151950 38-2206SP 18257200151981 38-2207SP 18257200151998 38-2208SP 18257200152001 38-2209SP 18257200152018 38-2210SP 18257200152025 38-2211SP 18257200152032 38-2212SP 18257200152049 38-2213SP 18257200152056 38-2214SP 18257200152063 38-2309SP 18257200152094 38-2310SP 18257200152100 38-2311SP 18257200152117 38-2312SP 18257200152124 38-2313SP 18257200152131 38-2314SP 18257200152148 38-2508SP 18257200152360 38-2509SP 18257200152377 38-2510SP 18257200152384 38-2511SP 18257200152391 38-2512SP 18257200152407 38-2513SP 18257200152414 38-2514SP 18257200152421 38-3206SP 18257200152179 38-3207SP 18257200152186 38-3208SP 18257200152193 38-3209SP 18257200152209 38-3210SP 18257200152216 38-3211SP 18257200152223 38-3212SP 18257200152230 38-3213SP 18257200152247 38-3214SP 18257200152254 38-3409SP 18257200152285 38-3410SP 18257200152292 38-3411SP 18257200152308 38-3412SP 18257200152315 38-3413SP 18257200152322 38-3414SP 18257200152339 38-3506SP 18257200152759 38-3507SP 18257200152766 38-3508SP 18257200152773 38-3509SP 18257200152780 38-3510SP 18257200152797 38-3511SP 18257200152803 38-3512SP 18257200152810 38-3513SP 18257200152827 38-3514SP 18257200152834 38-3608SP 18257200152865 38-3609SP 18257200152872 38-3610SP 18257200152889 38-3611SP 18257200152896 38-3612SP 18257200152902 38-3613SP 18257200152919 38-3614SP 18257200152926 38-3706SP 18257200152957 38-3707SP 18257200152964 38-3708SP 18257200152971 38-3709SP 18257200152988 38-3710SP 18257200152995 38-3711SP 18257200153008 38-3712SP 18257200153015 38-3713SP 18257200153022 38-3714SP 18257200153039 38-3808SP 18257200153060 38-3809SP 18257200153077 38-3810SP 18257200153084 38-3811SP 18257200153091 38-3812SP 18257200153107 38-3813SP 18257200153114 38-3814SP 18257200153121 38-3908SP 18257200153152 38-3909SP 18257200153169 38-3910SP 18257200153176 38-3911SP 18257200153183 38-3912SP 18257200153190 38-3913SP 18257200153206 38-3914SP 18257200153213",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}