{
  "@context": {
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    "@vocab": "https://schema.org/",
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      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0892-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Brand Name: FORZA\" PTC Spacer System  Product Name: FORZA\" PTC Spacer System  Model/Catalog Number: 38-1007SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H  38-1008SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H;  38-1009SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H;  38-1010SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 10H;  38-1011SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 11H;  38-1012SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 12H;  38-1013SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 13H;  38-1014SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 14H;  38-1707SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 7H;  38-1708SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 8H;  38-1709SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 9H;  38-1710SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 10H;  38-1711SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 11H;  38-1712SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 12H;  38-1713SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 13H;  38-1714SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 14H;  38-1807SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 7H;  38-1808SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 8H;  38-1809SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 9H;  38-1810SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 10H;  38-1811SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 11H;  38-1812SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 12H;  38-1813SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 13H;  38-1814SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 14H;  38-3007SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 7H;  38-3008SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 8H;  38-3009SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 9H;  38-3010SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 10H;  38-3011SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 11H;  38-3012SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 12H;  38-3013SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 13H;  38-3014SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 14H;  38-4007SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 7H;  38-4008SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 8H;  38-4009SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 9H;  38-4010SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 10H;  38-4011SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 11H;  38-4012SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 12H;  38-4013SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 13H;  38-4014SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 14H;  38-4207SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 7H;  38-4208SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 8H;  38-4209SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 9H;  38-4210SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 10H;  38-4211SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 11H;  38-4212SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 12H;  38-4213SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 13H;  38-4214SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 14H;  38-4508SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 8H;  38-4509SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 9H;  38-4510SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 10H;  38-4511SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 11H;  38-4512SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 12H;  38-4513SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 13H;  38-4514SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 14H;  38-6007SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 7H;  38-6008SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 8H;  38-6009SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 9H;  38-6010SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 10H;  38-6011SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 11H;  38-6012SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 12H;  38-6013SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 13H;  38-6014SP\tFORZA PTC Spacer,",
  "description": "FDA recall Z-0892-2026 — Orthofix U.S. LLC is recalling Brand Name: FORZA\" PTC Spacer System  Product Name: FORZA\" PTC Spacer System  Model/Catalog Number: 38-1007SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H  38-1008SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H;  38-1009SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H;  38-1010SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 10H;  38-1011SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 11H;  38-1012SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 12H;  38-1013SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 13H;  38-1014SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 14H;  38-1707SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 7H;  38-1708SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 8H;  38-1709SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 9H;  38-1710SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 10H;  38-1711SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 11H;  38-1712SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 12H;  38-1713SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 13H;  38-1714SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 14H;  38-1807SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 7H;  38-1808SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 8H;  38-1809SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 9H;  38-1810SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 10H;  38-1811SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 11H;  38-1812SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 12H;  38-1813SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 13H;  38-1814SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 14H;  38-3007SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 7H;  38-3008SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 8H;  38-3009SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 9H;  38-3010SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 10H;  38-3011SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 11H;  38-3012SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 12H;  38-3013SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 13H;  38-3014SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 14H;  38-4007SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 7H;  38-4008SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 8H;  38-4009SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 9H;  38-4010SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 10H;  38-4011SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 11H;  38-4012SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 12H;  38-4013SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 13H;  38-4014SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 14H;  38-4207SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 7H;  38-4208SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 8H;  38-4209SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 9H;  38-4210SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 10H;  38-4211SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 11H;  38-4212SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 12H;  38-4213SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 13H;  38-4214SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 14H;  38-4508SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 8H;  38-4509SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 9H;  38-4510SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 10H;  38-4511SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 11H;  38-4512SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 12H;  38-4513SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 13H;  38-4514SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 14H;  38-6007SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 7H;  38-6008SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 8H;  38-6009SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 9H;  38-6010SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 10H;  38-6011SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 11H;  38-6012SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 12H;  38-6013SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 13H;  38-6014SP\tFORZA PTC Spacer, (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"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0892-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: FORZA\" PTC Spacer System  Product Name: FORZA\" PTC Spacer System  Model/Catalog Number: 38-1007SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H  38-1008SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H;  38-1009SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H;  38-1010SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 10H;  38-1011SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 11H;  38-1012SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 12H;  38-1013SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 13H;  38-1014SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 14H;  38-1707SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 7H;  38-1708SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 8H;  38-1709SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 9H;  38-1710SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 10H;  38-1711SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 11H;  38-1712SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 12H;  38-1713SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 13H;  38-1714SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 14H;  38-1807SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 7H;  38-1808SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 8H;  38-1809SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 9H;  38-1810SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 10H;  38-1811SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 11H;  38-1812SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 12H;  38-1813SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 13H;  38-1814SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 14H;  38-3007SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 7H;  38-3008SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 8H;  38-3009SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 9H;  38-3010SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 10H;  38-3011SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 11H;  38-3012SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 12H;  38-3013SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 13H;  38-3014SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 14H;  38-4007SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 7H;  38-4008SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 8H;  38-4009SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 9H;  38-4010SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 10H;  38-4011SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 11H;  38-4012SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 12H;  38-4013SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 13H;  38-4014SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 14H;  38-4207SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 7H;  38-4208SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 8H;  38-4209SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 9H;  38-4210SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 10H;  38-4211SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 11H;  38-4212SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 12H;  38-4213SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 13H;  38-4214SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 14H;  38-4508SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 8H;  38-4509SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 9H;  38-4510SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 10H;  38-4511SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 11H;  38-4512SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 12H;  38-4513SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 13H;  38-4514SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 14H;  38-6007SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 7H;  38-6008SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 8H;  38-6009SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 9H;  38-6010SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 10H;  38-6011SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 11H;  38-6012SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 12H;  38-6013SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 13H;  38-6014SP\tFORZA PTC Spacer,",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Orthofix U.S. LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0892-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0892-2026: Orthofix U.S. LLC is recalling Brand Name: FORZA\" PTC Spacer System  Product Name: FORZA\" PTC Spacer System  Model/Catalog Number: 38-1007SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H  38-1008SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H;  38-1009SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H;  38-1010SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 10H;  38-1011SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 11H;  38-1012SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 12H;  38-1013SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 13H;  38-1014SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 14H;  38-1707SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 7H;  38-1708SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 8H;  38-1709SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 9H;  38-1710SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 10H;  38-1711SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 11H;  38-1712SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 12H;  38-1713SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 13H;  38-1714SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 14H;  38-1807SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 7H;  38-1808SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 8H;  38-1809SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 9H;  38-1810SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 10H;  38-1811SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 11H;  38-1812SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 12H;  38-1813SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 13H;  38-1814SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 14H;  38-3007SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 7H;  38-3008SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 8H;  38-3009SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 9H;  38-3010SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 10H;  38-3011SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 11H;  38-3012SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 12H;  38-3013SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 13H;  38-3014SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 14H;  38-4007SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 7H;  38-4008SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 8H;  38-4009SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 9H;  38-4010SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 10H;  38-4011SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 11H;  38-4012SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 12H;  38-4013SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 13H;  38-4014SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 14H;  38-4207SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 7H;  38-4208SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 8H;  38-4209SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 9H;  38-4210SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 10H;  38-4211SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 11H;  38-4212SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 12H;  38-4213SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 13H;  38-4214SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 14H;  38-4508SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 8H;  38-4509SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 9H;  38-4510SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 10H;  38-4511SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 11H;  38-4512SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 12H;  38-4513SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 13H;  38-4514SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 14H;  38-6007SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 7H;  38-6008SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 8H;  38-6009SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 9H;  38-6010SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 10H;  38-6011SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 11H;  38-6012SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 12H;  38-6013SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 13H;  38-6014SP\tFORZA PTC Spacer,",
      "text": "The FDA logged enforcement record Z-0892-2026: Orthofix U.S. LLC is voluntarily recalling Brand Name: FORZA\" PTC Spacer System  Product Name: FORZA\" PTC Spacer System  Model/Catalog Number: 38-1007SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H  38-1008SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H;  38-1009SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H;  38-1010SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 10H;  38-1011SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 11H;  38-1012SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 12H;  38-1013SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 13H;  38-1014SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 23L x 14H;  38-1707SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 7H;  38-1708SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 8H;  38-1709SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 9H;  38-1710SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 10H;  38-1711SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 11H;  38-1712SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 12H;  38-1713SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 13H;  38-1714SP\tFORZA PTC Spacer, Curved, 0¿, 9W x 27L x 14H;  38-1807SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 7H;  38-1808SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 8H;  38-1809SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 9H;  38-1810SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 10H;  38-1811SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 11H;  38-1812SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 12H;  38-1813SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 13H;  38-1814SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 27L x 14H;  38-3007SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 7H;  38-3008SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 8H;  38-3009SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 9H;  38-3010SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 10H;  38-3011SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 11H;  38-3012SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 12H;  38-3013SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 13H;  38-3014SP\tFORZA PTC Spacer, Straight, 0¿, 9W x 27L x 14H;  38-4007SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 7H;  38-4008SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 8H;  38-4009SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 9H;  38-4010SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 10H;  38-4011SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 11H;  38-4012SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 12H;  38-4013SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 13H;  38-4014SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 27L x 14H;  38-4207SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 7H;  38-4208SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 8H;  38-4209SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 9H;  38-4210SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 10H;  38-4211SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 11H;  38-4212SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 12H;  38-4213SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 13H;  38-4214SP\tFORZA PTC Spacer, Curved, 0¿, 11W x 31L x 14H;  38-4508SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 8H;  38-4509SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 9H;  38-4510SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 10H;  38-4511SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 11H;  38-4512SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 12H;  38-4513SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 13H;  38-4514SP\tFORZA PTC Spacer, Curved, 8¿, 9W x 27L x 14H;  38-6007SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 7H;  38-6008SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 8H;  38-6009SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 9H;  38-6010SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 10H;  38-6011SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 11H;  38-6012SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 12H;  38-6013SP\tFORZA PTC Spacer, Straight, 0¿, 11W x 31L x 13H;  38-6014SP\tFORZA PTC Spacer, — 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: 38-1007SP 18257200091577 38-1008SP 18257200091584 38-1009SP 18257200091591 38-1010SP 18257200111404 38-1011SP 18257200091614 38-1012SP 18257200091621 38-1013SP 18257200091638 38-1014SP 18257200091645 38-1707SP 18257200092185 38-1708SP 18257200092192 38-1709SP 18257200092208 38-1710SP 18257200092215 38-1711SP 18257200092222 38-1712SP 18257200092239 38-1713SP 18257200092246 38-1714SP 18257200092253 38-1807SP 18257200092024 38-1808SP 18257200092031 38-1809SP 18257200092048 38-1810SP 18257200092055 38-1811SP 18257200092062 38-1812SP 18257200092079 38-1813SP 18257200111305 38-1814SP 18257200092093 38-3007SP 18257200091881 38-3008SP 18257200091898 38-3009SP 18257200091904 38-3010SP 18257200091911 38-3011SP 18257200091928 38-3012SP 18257200091935 38-3013SP 18257200091942 38-3014SP 18257200091959 38-4007SP 18257200091720 38-4008SP 18257200091737 38-4009SP 18257200091744 38-4010SP 18257200091751 38-4011SP 18257200111411 38-4012SP 18257200091775 Part Number GTIN 38-4013SP 18257200091782 38-4014SP 18257200091799 38-4207SP 18257200092109 38-4208SP 18257200092116 38-4209SP 18257200092123 38-4210SP 18257200092130 38-4211SP 18257200092147 38-4212SP 18257200092154 38-4213SP 18257200092161 38-4214SP 18257200092178 38-4508SP 18257200092260 38-4509SP 18257200092277 38-4510SP 18257200092284 38-4511SP 18257200092291 38-4512SP 18257200092307 38-4513SP 18257200092314 38-4514SP 18257200092321 38-6007SP 18257200091805 38-6008SP 18257200091812 38-6009SP 18257200091829 38-6010SP 18257200091836 38-6011SP 18257200091843 38-6012SP 18257200091850 38-6013SP 18257200091867 38-6014SP 18257200091874 38-7008SP 18257200091652 38-7009SP 18257200091669 38-7010SP 18257200091676 38-7011SP 18257200091683 38-7012SP 18257200091690 38-7013SP 18257200091706 38-7014SP 18257200091713 38-9009SP 18257200091966 38-9010SP 18257200091973 38-9011SP 18257200091980 38-9012SP 18257200091997 38-9013SP 18257200092000 38-9014SP 18257200092017. 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-0892-2026&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-0892-2026&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-0892-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0892-2026 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-0892-2026&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-0892-2026&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-0892-2026/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-0892-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0892-2026",
            "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: 38-1007SP 18257200091577 38-1008SP 18257200091584 38-1009SP 18257200091591 38-1010SP 18257200111404 38-1011SP 18257200091614 38-1012SP 18257200091621 38-1013SP 18257200091638 38-1014SP 18257200091645 38-1707SP 18257200092185 38-1708SP 18257200092192 38-1709SP 18257200092208 38-1710SP 18257200092215 38-1711SP 18257200092222 38-1712SP 18257200092239 38-1713SP 18257200092246 38-1714SP 18257200092253 38-1807SP 18257200092024 38-1808SP 18257200092031 38-1809SP 18257200092048 38-1810SP 18257200092055 38-1811SP 18257200092062 38-1812SP 18257200092079 38-1813SP 18257200111305 38-1814SP 18257200092093 38-3007SP 18257200091881 38-3008SP 18257200091898 38-3009SP 18257200091904 38-3010SP 18257200091911 38-3011SP 18257200091928 38-3012SP 18257200091935 38-3013SP 18257200091942 38-3014SP 18257200091959 38-4007SP 18257200091720 38-4008SP 18257200091737 38-4009SP 18257200091744 38-4010SP 18257200091751 38-4011SP 18257200111411 38-4012SP 18257200091775 Part Number GTIN 38-4013SP 18257200091782 38-4014SP 18257200091799 38-4207SP 18257200092109 38-4208SP 18257200092116 38-4209SP 18257200092123 38-4210SP 18257200092130 38-4211SP 18257200092147 38-4212SP 18257200092154 38-4213SP 18257200092161 38-4214SP 18257200092178 38-4508SP 18257200092260 38-4509SP 18257200092277 38-4510SP 18257200092284 38-4511SP 18257200092291 38-4512SP 18257200092307 38-4513SP 18257200092314 38-4514SP 18257200092321 38-6007SP 18257200091805 38-6008SP 18257200091812 38-6009SP 18257200091829 38-6010SP 18257200091836 38-6011SP 18257200091843 38-6012SP 18257200091850 38-6013SP 18257200091867 38-6014SP 18257200091874 38-7008SP 18257200091652 38-7009SP 18257200091669 38-7010SP 18257200091676 38-7011SP 18257200091683 38-7012SP 18257200091690 38-7013SP 18257200091706 38-7014SP 18257200091713 38-9009SP 18257200091966 38-9010SP 18257200091973 38-9011SP 18257200091980 38-9012SP 18257200091997 38-9013SP 18257200092000 38-9014SP 18257200092017",
            "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"
          }
        }
      ]
    }
  ]
}