{
  "@context": {
    "schema": "https://schema.org/",
    "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",
    "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-0891-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Brand Name: CONSTRUX\" Mini PTC Spacer System  Product Name: CONSTRUX\" Mini PTC Spacer System  Model/Catalog Number: 37-3106SP\t12mm W  X 12mm L, 6mm H, Parallel;  37-3107SP\t12mm W  X 12mm L, 7mm H, Parallel;  37-3108SP\t12mm W  X 12mm L, 8mm H, Parallel;  37-3109SP\t12mm W  X 12mm L, 9mm H, Parallel;  37-3110SP\t12mm W  X 12mm L, 10mm H, Parallel;  37-3111SP\t12mm W  X 12mm L, 11mm H, Parallel;  37-3112SP\t12mm W  X 12mm L, 12mm H, Parallel;  37-3113SP\t12mm W  X 12mm LW, 13mm H, Parallel;  37-3114SP\t12mm W  X 12mm WL, 14mm H, Parallel;  37-3006SP\t12mm W X 12mm L, 6mm H, 5¿ Lordotic;  37-3007SP\t12mm W X 12mm L, 7mm H, 5¿ Lordotic;  37-3008SP\t12mm W X 12mm L, 8mm H, 5¿ Lordotic;  37-3009SP\t12mm WL X 12mm L, 9mm H, 5¿ Lordotic;  37-3010SP\t12mm W X 12mm L, 10mm H, 5¿ Lordotic;  37-3011SP\t12mm W X 12mm L, 11mm H, 5¿ Lordotic;  37-3012SP\t12mm W X 12mm L, 12mm H, 5¿ Lordotic;  37-3013SP\t12mm W X 12mm L, 13mm H, 5¿ Lordotic;  37-3014SP\t12mm W X 12mm L, 14mm H, 5¿ Lordotic;  37-3207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic;  37-3208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic;  37-3209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic;  37-3210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic;  37-3211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic;  37-3212SP\t12mm W X 12mm L, 12mm H, 10¿ Lordotic;  37-4106SP\t15mm W X 12mm L, 6mm H, Parallel;  37-4107SP\t15mm W X 12mm L, 7mm H, Parallel;  37-4108SP\t15mm W X 12mm L, 8mm H, Parallel;  37-4109SP\t15mm W X 12mm L, 9mm H, Parallel;  37-4110SP\t15mm W X 12mm L, 10mm H, Parallel;  37-4111SP\t15mm W X 12mm L, 11mm H, Parallel;  37-4112SP\t15mm W X 12mm L, 12mm H, Parallel;  37-4113SP\t15mm W X 12mm L, 13mm H, Parallel;  37-4114SP\t15mm W X 12mm L, 14mm H, Parallel;  37-4006SP\t15mm W X 12mm L, 6mm H, 5¿ Lordotic;  37-4007SP\t15mm W X 12mm L, 7mm H, 5¿ Lordotic;  37-4008SP\t15mm W X 12mm L, 8mm H, 5¿ Lordotic;  37-4009SP\t15mm W X 12mm L, 9mm H, 5¿ Lordotic;  37-4010SP\t15mm W X 12mm L, 10mm H, 5¿ Lordotic;  37-4011SP\t15mm W X 12mm L, 11mm H, 5¿ Lordotic;  37-4012SP\t15mm W X 12mm L, 12mm H, 5¿ Lordotic;  37-4013SP\t15mm W X 12mm L, 13mm H, 5¿ Lordotic;  37-4014SP\t15mm W X 12mm L, 14mm H, 5¿ Lordotic;  37-4207SP\t15mm W X 12mm L, 7mm H, 10¿ Lordotic;  37-4208SP\t15mm W X 12mm L, 8mm H, 10¿ Lordotic;  37-4209SP\t15mm W X 12mm L, 9mm H, 10¿ Lordotic;  37-4210SP\t15mm W X 12mm L, 10mm H, 10¿ Lordotic;  37-4211SP\t15mm W X 12mm L, 11mm H, 10¿ Lordotic;  37-4212SP\t15mm W X 12mm L, 12mm H, 10¿ Lordotic;  37-5106SP\t15mm W X 15mm L, 6mm H, Parallel;  37-5107SP\t15mm W X 15mm L, 7mm H, Parallel  37-5108SP\t15mm W X 15mm L, 8mm H, Parallel;  37-5109SP\t15mm W X 15mm L, 9mm H, Parallel;  37-5110SP\t15mm W X 15mm L, 10mm H, Parallel;  37-5111SP\t15mm W X 15mm L, 11mm H, Parallel;  37-5112SP\t15mm W X 15mm L, 12mm H, Parallel;  37-5113SP\t15mm W X 15mm L, 13mm H, Parallel;  37-5114SP\t15mm W X 15mm L, 14mm H, Parallel;  37-5006SP\t15mm W X 15mm L, 6mm H, 5¿ Lordotic;  37-5007SP\t15mm W X 15mm L, 7mm H, 5¿ Lordotic;  37-5008SP\t15mm W X 15mm L, 8mm H, 5¿ Lordotic;  37-5009SP\t15mm W X 15mm L, 9mm H, 5¿ Lordotic;  37-5010SP\t15mm W X 15mm L, 10mm H, 5¿ Lordotic;  37-5011SP\t15mm W X 15mm L, 11mm H, 5¿ Lordotic;  37-5012SP\t15mm W X 15mm L, 12mm H, 5¿ Lordotic;  37-5013SP\t15mm W X 15mm L, 13mm H, 5¿ Lordotic;  37-5014SP\t15mm W X 15mm L, 14mm H, 5¿ Lordotic;  37-5207SP\t15mm W X 15mm L, 7mm H, 10¿ Lordotic;  37-5208SP\t15mm W X 15mm L, 8mm H, 10¿ Lordotic;  37-5209SP\t15mm W X 15mm LW, 9mm H, 10¿ Lordotic;  37-5210SP\t15mm W X 15mm L, 10mm H, 10¿ Lordotic;  37-5211SP\t15mm W X 15mm L, 11mm H, 10¿ Lordotic;  37-5212SP\t15mm W X 15mm L, 12mm H, 10¿ Lordotic;",
  "description": "FDA recall Z-0891-2026 — Orthofix U.S. LLC is recalling Brand Name: CONSTRUX\" Mini PTC Spacer System  Product Name: CONSTRUX\" Mini PTC Spacer System  Model/Catalog Number: 37-3106SP\t12mm W  X 12mm L, 6mm H, Parallel;  37-3107SP\t12mm W  X 12mm L, 7mm H, Parallel;  37-3108SP\t12mm W  X 12mm L, 8mm H, Parallel;  37-3109SP\t12mm W  X 12mm L, 9mm H, Parallel;  37-3110SP\t12mm W  X 12mm L, 10mm H, Parallel;  37-3111SP\t12mm W  X 12mm L, 11mm H, Parallel;  37-3112SP\t12mm W  X 12mm L, 12mm H, Parallel;  37-3113SP\t12mm W  X 12mm LW, 13mm H, Parallel;  37-3114SP\t12mm W  X 12mm WL, 14mm H, Parallel;  37-3006SP\t12mm W X 12mm L, 6mm H, 5¿ Lordotic;  37-3007SP\t12mm W X 12mm L, 7mm H, 5¿ Lordotic;  37-3008SP\t12mm W X 12mm L, 8mm H, 5¿ Lordotic;  37-3009SP\t12mm WL X 12mm L, 9mm H, 5¿ Lordotic;  37-3010SP\t12mm W X 12mm L, 10mm H, 5¿ Lordotic;  37-3011SP\t12mm W X 12mm L, 11mm H, 5¿ Lordotic;  37-3012SP\t12mm W X 12mm L, 12mm H, 5¿ Lordotic;  37-3013SP\t12mm W X 12mm L, 13mm H, 5¿ Lordotic;  37-3014SP\t12mm W X 12mm L, 14mm H, 5¿ Lordotic;  37-3207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic;  37-3208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic;  37-3209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic;  37-3210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic;  37-3211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic;  37-3212SP\t12mm W X 12mm L, 12mm H, 10¿ Lordotic;  37-4106SP\t15mm W X 12mm L, 6mm H, Parallel;  37-4107SP\t15mm W X 12mm L, 7mm H, Parallel;  37-4108SP\t15mm W X 12mm L, 8mm H, Parallel;  37-4109SP\t15mm W X 12mm L, 9mm H, Parallel;  37-4110SP\t15mm W X 12mm L, 10mm H, Parallel;  37-4111SP\t15mm W X 12mm L, 11mm H, Parallel;  37-4112SP\t15mm W X 12mm L, 12mm H, Parallel;  37-4113SP\t15mm W X 12mm L, 13mm H, Parallel;  37-4114SP\t15mm W X 12mm L, 14mm H, Parallel;  37-4006SP\t15mm W X 12mm L, 6mm H, 5¿ Lordotic;  37-4007SP\t15mm W X 12mm L, 7mm H, 5¿ Lordotic;  37-4008SP\t15mm W X 12mm L, 8mm H, 5¿ Lordotic;  37-4009SP\t15mm W X 12mm L, 9mm H, 5¿ Lordotic;  37-4010SP\t15mm W X 12mm L, 10mm H, 5¿ Lordotic;  37-4011SP\t15mm W X 12mm L, 11mm H, 5¿ Lordotic;  37-4012SP\t15mm W X 12mm L, 12mm H, 5¿ Lordotic;  37-4013SP\t15mm W X 12mm L, 13mm H, 5¿ Lordotic;  37-4014SP\t15mm W X 12mm L, 14mm H, 5¿ Lordotic;  37-4207SP\t15mm W X 12mm L, 7mm H, 10¿ Lordotic;  37-4208SP\t15mm W X 12mm L, 8mm H, 10¿ Lordotic;  37-4209SP\t15mm W X 12mm L, 9mm H, 10¿ Lordotic;  37-4210SP\t15mm W X 12mm L, 10mm H, 10¿ Lordotic;  37-4211SP\t15mm W X 12mm L, 11mm H, 10¿ Lordotic;  37-4212SP\t15mm W X 12mm L, 12mm H, 10¿ Lordotic;  37-5106SP\t15mm W X 15mm L, 6mm H, Parallel;  37-5107SP\t15mm W X 15mm L, 7mm H, Parallel  37-5108SP\t15mm W X 15mm L, 8mm H, Parallel;  37-5109SP\t15mm W X 15mm L, 9mm H, Parallel;  37-5110SP\t15mm W X 15mm L, 10mm H, Parallel;  37-5111SP\t15mm W X 15mm L, 11mm H, Parallel;  37-5112SP\t15mm W X 15mm L, 12mm H, Parallel;  37-5113SP\t15mm W X 15mm L, 13mm H, Parallel;  37-5114SP\t15mm W X 15mm L, 14mm H, Parallel;  37-5006SP\t15mm W X 15mm L, 6mm H, 5¿ Lordotic;  37-5007SP\t15mm W X 15mm L, 7mm H, 5¿ Lordotic;  37-5008SP\t15mm W X 15mm L, 8mm H, 5¿ Lordotic;  37-5009SP\t15mm W X 15mm L, 9mm H, 5¿ Lordotic;  37-5010SP\t15mm W X 15mm L, 10mm H, 5¿ Lordotic;  37-5011SP\t15mm W X 15mm L, 11mm H, 5¿ Lordotic;  37-5012SP\t15mm W X 15mm L, 12mm H, 5¿ Lordotic;  37-5013SP\t15mm W X 15mm L, 13mm H, 5¿ Lordotic;  37-5014SP\t15mm W X 15mm L, 14mm H, 5¿ Lordotic;  37-5207SP\t15mm W X 15mm L, 7mm H, 10¿ Lordotic;  37-5208SP\t15mm W X 15mm L, 8mm H, 10¿ Lordotic;  37-5209SP\t15mm W X 15mm LW, 9mm H, 10¿ Lordotic;  37-5210SP\t15mm W X 15mm L, 10mm H, 10¿ Lordotic;  37-5211SP\t15mm W X 15mm L, 11mm H, 10¿ Lordotic;  37-5212SP\t15mm W X 15mm L, 12mm 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.",
  "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-0891-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: CONSTRUX\" Mini PTC Spacer System  Product Name: CONSTRUX\" Mini PTC Spacer System  Model/Catalog Number: 37-3106SP\t12mm W  X 12mm L, 6mm H, Parallel;  37-3107SP\t12mm W  X 12mm L, 7mm H, Parallel;  37-3108SP\t12mm W  X 12mm L, 8mm H, Parallel;  37-3109SP\t12mm W  X 12mm L, 9mm H, Parallel;  37-3110SP\t12mm W  X 12mm L, 10mm H, Parallel;  37-3111SP\t12mm W  X 12mm L, 11mm H, Parallel;  37-3112SP\t12mm W  X 12mm L, 12mm H, Parallel;  37-3113SP\t12mm W  X 12mm LW, 13mm H, Parallel;  37-3114SP\t12mm W  X 12mm WL, 14mm H, Parallel;  37-3006SP\t12mm W X 12mm L, 6mm H, 5¿ Lordotic;  37-3007SP\t12mm W X 12mm L, 7mm H, 5¿ Lordotic;  37-3008SP\t12mm W X 12mm L, 8mm H, 5¿ Lordotic;  37-3009SP\t12mm WL X 12mm L, 9mm H, 5¿ Lordotic;  37-3010SP\t12mm W X 12mm L, 10mm H, 5¿ Lordotic;  37-3011SP\t12mm W X 12mm L, 11mm H, 5¿ Lordotic;  37-3012SP\t12mm W X 12mm L, 12mm H, 5¿ Lordotic;  37-3013SP\t12mm W X 12mm L, 13mm H, 5¿ Lordotic;  37-3014SP\t12mm W X 12mm L, 14mm H, 5¿ Lordotic;  37-3207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic;  37-3208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic;  37-3209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic;  37-3210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic;  37-3211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic;  37-3212SP\t12mm W X 12mm L, 12mm H, 10¿ Lordotic;  37-4106SP\t15mm W X 12mm L, 6mm H, Parallel;  37-4107SP\t15mm W X 12mm L, 7mm H, Parallel;  37-4108SP\t15mm W X 12mm L, 8mm H, Parallel;  37-4109SP\t15mm W X 12mm L, 9mm H, Parallel;  37-4110SP\t15mm W X 12mm L, 10mm H, Parallel;  37-4111SP\t15mm W X 12mm L, 11mm H, Parallel;  37-4112SP\t15mm W X 12mm L, 12mm H, Parallel;  37-4113SP\t15mm W X 12mm L, 13mm H, Parallel;  37-4114SP\t15mm W X 12mm L, 14mm H, Parallel;  37-4006SP\t15mm W X 12mm L, 6mm H, 5¿ Lordotic;  37-4007SP\t15mm W X 12mm L, 7mm H, 5¿ Lordotic;  37-4008SP\t15mm W X 12mm L, 8mm H, 5¿ Lordotic;  37-4009SP\t15mm W X 12mm L, 9mm H, 5¿ Lordotic;  37-4010SP\t15mm W X 12mm L, 10mm H, 5¿ Lordotic;  37-4011SP\t15mm W X 12mm L, 11mm H, 5¿ Lordotic;  37-4012SP\t15mm W X 12mm L, 12mm H, 5¿ Lordotic;  37-4013SP\t15mm W X 12mm L, 13mm H, 5¿ Lordotic;  37-4014SP\t15mm W X 12mm L, 14mm H, 5¿ Lordotic;  37-4207SP\t15mm W X 12mm L, 7mm H, 10¿ Lordotic;  37-4208SP\t15mm W X 12mm L, 8mm H, 10¿ Lordotic;  37-4209SP\t15mm W X 12mm L, 9mm H, 10¿ Lordotic;  37-4210SP\t15mm W X 12mm L, 10mm H, 10¿ Lordotic;  37-4211SP\t15mm W X 12mm L, 11mm H, 10¿ Lordotic;  37-4212SP\t15mm W X 12mm L, 12mm H, 10¿ Lordotic;  37-5106SP\t15mm W X 15mm L, 6mm H, Parallel;  37-5107SP\t15mm W X 15mm L, 7mm H, Parallel  37-5108SP\t15mm W X 15mm L, 8mm H, Parallel;  37-5109SP\t15mm W X 15mm L, 9mm H, Parallel;  37-5110SP\t15mm W X 15mm L, 10mm H, Parallel;  37-5111SP\t15mm W X 15mm L, 11mm H, Parallel;  37-5112SP\t15mm W X 15mm L, 12mm H, Parallel;  37-5113SP\t15mm W X 15mm L, 13mm H, Parallel;  37-5114SP\t15mm W X 15mm L, 14mm H, Parallel;  37-5006SP\t15mm W X 15mm L, 6mm H, 5¿ Lordotic;  37-5007SP\t15mm W X 15mm L, 7mm H, 5¿ Lordotic;  37-5008SP\t15mm W X 15mm L, 8mm H, 5¿ Lordotic;  37-5009SP\t15mm W X 15mm L, 9mm H, 5¿ Lordotic;  37-5010SP\t15mm W X 15mm L, 10mm H, 5¿ Lordotic;  37-5011SP\t15mm W X 15mm L, 11mm H, 5¿ Lordotic;  37-5012SP\t15mm W X 15mm L, 12mm H, 5¿ Lordotic;  37-5013SP\t15mm W X 15mm L, 13mm H, 5¿ Lordotic;  37-5014SP\t15mm W X 15mm L, 14mm H, 5¿ Lordotic;  37-5207SP\t15mm W X 15mm L, 7mm H, 10¿ Lordotic;  37-5208SP\t15mm W X 15mm L, 8mm H, 10¿ Lordotic;  37-5209SP\t15mm W X 15mm LW, 9mm H, 10¿ Lordotic;  37-5210SP\t15mm W X 15mm L, 10mm H, 10¿ Lordotic;  37-5211SP\t15mm W X 15mm L, 11mm H, 10¿ Lordotic;  37-5212SP\t15mm W X 15mm L, 12mm H, 10¿ Lordotic;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Orthofix U.S. LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0891-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0891-2026: Orthofix U.S. LLC is recalling Brand Name: CONSTRUX\" Mini PTC Spacer System  Product Name: CONSTRUX\" Mini PTC Spacer System  Model/Catalog Number: 37-3106SP\t12mm W  X 12mm L, 6mm H, Parallel;  37-3107SP\t12mm W  X 12mm L, 7mm H, Parallel;  37-3108SP\t12mm W  X 12mm L, 8mm H, Parallel;  37-3109SP\t12mm W  X 12mm L, 9mm H, Parallel;  37-3110SP\t12mm W  X 12mm L, 10mm H, Parallel;  37-3111SP\t12mm W  X 12mm L, 11mm H, Parallel;  37-3112SP\t12mm W  X 12mm L, 12mm H, Parallel;  37-3113SP\t12mm W  X 12mm LW, 13mm H, Parallel;  37-3114SP\t12mm W  X 12mm WL, 14mm H, Parallel;  37-3006SP\t12mm W X 12mm L, 6mm H, 5¿ Lordotic;  37-3007SP\t12mm W X 12mm L, 7mm H, 5¿ Lordotic;  37-3008SP\t12mm W X 12mm L, 8mm H, 5¿ Lordotic;  37-3009SP\t12mm WL X 12mm L, 9mm H, 5¿ Lordotic;  37-3010SP\t12mm W X 12mm L, 10mm H, 5¿ Lordotic;  37-3011SP\t12mm W X 12mm L, 11mm H, 5¿ Lordotic;  37-3012SP\t12mm W X 12mm L, 12mm H, 5¿ Lordotic;  37-3013SP\t12mm W X 12mm L, 13mm H, 5¿ Lordotic;  37-3014SP\t12mm W X 12mm L, 14mm H, 5¿ Lordotic;  37-3207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic;  37-3208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic;  37-3209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic;  37-3210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic;  37-3211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic;  37-3212SP\t12mm W X 12mm L, 12mm H, 10¿ Lordotic;  37-4106SP\t15mm W X 12mm L, 6mm H, Parallel;  37-4107SP\t15mm W X 12mm L, 7mm H, Parallel;  37-4108SP\t15mm W X 12mm L, 8mm H, Parallel;  37-4109SP\t15mm W X 12mm L, 9mm H, Parallel;  37-4110SP\t15mm W X 12mm L, 10mm H, Parallel;  37-4111SP\t15mm W X 12mm L, 11mm H, Parallel;  37-4112SP\t15mm W X 12mm L, 12mm H, Parallel;  37-4113SP\t15mm W X 12mm L, 13mm H, Parallel;  37-4114SP\t15mm W X 12mm L, 14mm H, Parallel;  37-4006SP\t15mm W X 12mm L, 6mm H, 5¿ Lordotic;  37-4007SP\t15mm W X 12mm L, 7mm H, 5¿ Lordotic;  37-4008SP\t15mm W X 12mm L, 8mm H, 5¿ Lordotic;  37-4009SP\t15mm W X 12mm L, 9mm H, 5¿ Lordotic;  37-4010SP\t15mm W X 12mm L, 10mm H, 5¿ Lordotic;  37-4011SP\t15mm W X 12mm L, 11mm H, 5¿ Lordotic;  37-4012SP\t15mm W X 12mm L, 12mm H, 5¿ Lordotic;  37-4013SP\t15mm W X 12mm L, 13mm H, 5¿ Lordotic;  37-4014SP\t15mm W X 12mm L, 14mm H, 5¿ Lordotic;  37-4207SP\t15mm W X 12mm L, 7mm H, 10¿ Lordotic;  37-4208SP\t15mm W X 12mm L, 8mm H, 10¿ Lordotic;  37-4209SP\t15mm W X 12mm L, 9mm H, 10¿ Lordotic;  37-4210SP\t15mm W X 12mm L, 10mm H, 10¿ Lordotic;  37-4211SP\t15mm W X 12mm L, 11mm H, 10¿ Lordotic;  37-4212SP\t15mm W X 12mm L, 12mm H, 10¿ Lordotic;  37-5106SP\t15mm W X 15mm L, 6mm H, Parallel;  37-5107SP\t15mm W X 15mm L, 7mm H, Parallel  37-5108SP\t15mm W X 15mm L, 8mm H, Parallel;  37-5109SP\t15mm W X 15mm L, 9mm H, Parallel;  37-5110SP\t15mm W X 15mm L, 10mm H, Parallel;  37-5111SP\t15mm W X 15mm L, 11mm H, Parallel;  37-5112SP\t15mm W X 15mm L, 12mm H, Parallel;  37-5113SP\t15mm W X 15mm L, 13mm H, Parallel;  37-5114SP\t15mm W X 15mm L, 14mm H, Parallel;  37-5006SP\t15mm W X 15mm L, 6mm H, 5¿ Lordotic;  37-5007SP\t15mm W X 15mm L, 7mm H, 5¿ Lordotic;  37-5008SP\t15mm W X 15mm L, 8mm H, 5¿ Lordotic;  37-5009SP\t15mm W X 15mm L, 9mm H, 5¿ Lordotic;  37-5010SP\t15mm W X 15mm L, 10mm H, 5¿ Lordotic;  37-5011SP\t15mm W X 15mm L, 11mm H, 5¿ Lordotic;  37-5012SP\t15mm W X 15mm L, 12mm H, 5¿ Lordotic;  37-5013SP\t15mm W X 15mm L, 13mm H, 5¿ Lordotic;  37-5014SP\t15mm W X 15mm L, 14mm H, 5¿ Lordotic;  37-5207SP\t15mm W X 15mm L, 7mm H, 10¿ Lordotic;  37-5208SP\t15mm W X 15mm L, 8mm H, 10¿ Lordotic;  37-5209SP\t15mm W X 15mm LW, 9mm H, 10¿ Lordotic;  37-5210SP\t15mm W X 15mm L, 10mm H, 10¿ Lordotic;  37-5211SP\t15mm W X 15mm L, 11mm H, 10¿ Lordotic;  37-5212SP\t15mm W X 15mm L, 12mm H, 10¿ Lordotic;",
      "text": "The FDA logged enforcement record Z-0891-2026: Orthofix U.S. LLC is voluntarily recalling Brand Name: CONSTRUX\" Mini PTC Spacer System  Product Name: CONSTRUX\" Mini PTC Spacer System  Model/Catalog Number: 37-3106SP\t12mm W  X 12mm L, 6mm H, Parallel;  37-3107SP\t12mm W  X 12mm L, 7mm H, Parallel;  37-3108SP\t12mm W  X 12mm L, 8mm H, Parallel;  37-3109SP\t12mm W  X 12mm L, 9mm H, Parallel;  37-3110SP\t12mm W  X 12mm L, 10mm H, Parallel;  37-3111SP\t12mm W  X 12mm L, 11mm H, Parallel;  37-3112SP\t12mm W  X 12mm L, 12mm H, Parallel;  37-3113SP\t12mm W  X 12mm LW, 13mm H, Parallel;  37-3114SP\t12mm W  X 12mm WL, 14mm H, Parallel;  37-3006SP\t12mm W X 12mm L, 6mm H, 5¿ Lordotic;  37-3007SP\t12mm W X 12mm L, 7mm H, 5¿ Lordotic;  37-3008SP\t12mm W X 12mm L, 8mm H, 5¿ Lordotic;  37-3009SP\t12mm WL X 12mm L, 9mm H, 5¿ Lordotic;  37-3010SP\t12mm W X 12mm L, 10mm H, 5¿ Lordotic;  37-3011SP\t12mm W X 12mm L, 11mm H, 5¿ Lordotic;  37-3012SP\t12mm W X 12mm L, 12mm H, 5¿ Lordotic;  37-3013SP\t12mm W X 12mm L, 13mm H, 5¿ Lordotic;  37-3014SP\t12mm W X 12mm L, 14mm H, 5¿ Lordotic;  37-3207SP\t12mm W X 12mm L, 7mm H, 10¿ Lordotic;  37-3208SP\t12mm W X 12mm L, 8mm H, 10¿ Lordotic;  37-3209SP\t12mm W X 12mm L, 9mm H, 10¿ Lordotic;  37-3210SP\t12mm W X 12mm L, 10mm H, 10¿ Lordotic;  37-3211SP\t12mm W X 12mm L, 11mm H, 10¿ Lordotic;  37-3212SP\t12mm W X 12mm L, 12mm H, 10¿ Lordotic;  37-4106SP\t15mm W X 12mm L, 6mm H, Parallel;  37-4107SP\t15mm W X 12mm L, 7mm H, Parallel;  37-4108SP\t15mm W X 12mm L, 8mm H, Parallel;  37-4109SP\t15mm W X 12mm L, 9mm H, Parallel;  37-4110SP\t15mm W X 12mm L, 10mm H, Parallel;  37-4111SP\t15mm W X 12mm L, 11mm H, Parallel;  37-4112SP\t15mm W X 12mm L, 12mm H, Parallel;  37-4113SP\t15mm W X 12mm L, 13mm H, Parallel;  37-4114SP\t15mm W X 12mm L, 14mm H, Parallel;  37-4006SP\t15mm W X 12mm L, 6mm H, 5¿ Lordotic;  37-4007SP\t15mm W X 12mm L, 7mm H, 5¿ Lordotic;  37-4008SP\t15mm W X 12mm L, 8mm H, 5¿ Lordotic;  37-4009SP\t15mm W X 12mm L, 9mm H, 5¿ Lordotic;  37-4010SP\t15mm W X 12mm L, 10mm H, 5¿ Lordotic;  37-4011SP\t15mm W X 12mm L, 11mm H, 5¿ Lordotic;  37-4012SP\t15mm W X 12mm L, 12mm H, 5¿ Lordotic;  37-4013SP\t15mm W X 12mm L, 13mm H, 5¿ Lordotic;  37-4014SP\t15mm W X 12mm L, 14mm H, 5¿ Lordotic;  37-4207SP\t15mm W X 12mm L, 7mm H, 10¿ Lordotic;  37-4208SP\t15mm W X 12mm L, 8mm H, 10¿ Lordotic;  37-4209SP\t15mm W X 12mm L, 9mm H, 10¿ Lordotic;  37-4210SP\t15mm W X 12mm L, 10mm H, 10¿ Lordotic;  37-4211SP\t15mm W X 12mm L, 11mm H, 10¿ Lordotic;  37-4212SP\t15mm W X 12mm L, 12mm H, 10¿ Lordotic;  37-5106SP\t15mm W X 15mm L, 6mm H, Parallel;  37-5107SP\t15mm W X 15mm L, 7mm H, Parallel  37-5108SP\t15mm W X 15mm L, 8mm H, Parallel;  37-5109SP\t15mm W X 15mm L, 9mm H, Parallel;  37-5110SP\t15mm W X 15mm L, 10mm H, Parallel;  37-5111SP\t15mm W X 15mm L, 11mm H, Parallel;  37-5112SP\t15mm W X 15mm L, 12mm H, Parallel;  37-5113SP\t15mm W X 15mm L, 13mm H, Parallel;  37-5114SP\t15mm W X 15mm L, 14mm H, Parallel;  37-5006SP\t15mm W X 15mm L, 6mm H, 5¿ Lordotic;  37-5007SP\t15mm W X 15mm L, 7mm H, 5¿ Lordotic;  37-5008SP\t15mm W X 15mm L, 8mm H, 5¿ Lordotic;  37-5009SP\t15mm W X 15mm L, 9mm H, 5¿ Lordotic;  37-5010SP\t15mm W X 15mm L, 10mm H, 5¿ Lordotic;  37-5011SP\t15mm W X 15mm L, 11mm H, 5¿ Lordotic;  37-5012SP\t15mm W X 15mm L, 12mm H, 5¿ Lordotic;  37-5013SP\t15mm W X 15mm L, 13mm H, 5¿ Lordotic;  37-5014SP\t15mm W X 15mm L, 14mm H, 5¿ Lordotic;  37-5207SP\t15mm W X 15mm L, 7mm H, 10¿ Lordotic;  37-5208SP\t15mm W X 15mm L, 8mm H, 10¿ Lordotic;  37-5209SP\t15mm W X 15mm LW, 9mm H, 10¿ Lordotic;  37-5210SP\t15mm W X 15mm L, 10mm H, 10¿ Lordotic;  37-5211SP\t15mm W X 15mm L, 11mm H, 10¿ Lordotic;  37-5212SP\t15mm W X 15mm L, 12mm 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 Lots/ UDI: 37-3106SP 18257200030590 37-3107SP 18257200030613 37-3108SP 18257200030637 37-3109SP 18257200030651 37-3110SP 18257200030675 37-3111SP 18257200030699 37-3112SP 18257200030712 37-3113SP 18257200030736 37-3114SP 18257200030750 37-3006SP 18257200030415 37-3007SP 18257200030439 37-3008SP 18257200030453 37-3009SP 18257200030477 37-3010SP 18257200030491 37-3011SP 18257200030514 37-3012SP 18257200030538 37-3013SP 18257200030552 37-3014SP 18257200030576 37-3207SP 18257200146352 37-3208SP 18257200146369 37-3209SP 18257200146376 37-3210SP 18257200146383 37-3211SP 18257200146390 37-3212SP 18257200146406 37-4106SP 18257200030958 37-4107SP 18257200030972 37-4108SP 18257200030996 37-4109SP 18257200031016 37-4110SP 18257200031030 37-4111SP 18257200031054 37-4112SP 18257200031078 37-4113SP 18257200031092 37-4114SP 18257200031115 37-4006SP 18257200030774 37-4007SP 18257200030798 Part Number GTIN 37-4008SP 18257200030811 37-4009SP 18257200030835 37-4010SP 18257200030859 37-4011SP 18257200030873 37-4012SP 18257200030897 37-4013SP 18257200030910 37-4014SP 18257200030934 37-4207SP 18257200146420 37-4208SP 18257200146437 37-4209SP 18257200146444 37-4210SP 18257200146451 37-4211SP 18257200146468 37-4212SP 18257200146475 37-5106SP 18257200031313 37-5107SP 18257200031337 37-5108SP 18257200031351 37-5109SP 18257200031375 37-5110SP 18257200031399 37-5111SP 18257200031412 37-5112SP 18257200031436 37-5113SP 18257200031450 37-5114SP 18257200031474 37-5006SP 18257200031139 37-5007SP 18257200031153 37-5008SP 18257200031177 37-5009SP 18257200031191 37-5010SP 18257200031214 37-5011SP 18257200031238 37-5012SP 18257200031252 37-5013SP 18257200031276 37-5014SP 18257200031290 37-5207SP 18257200146505 37-5208SP 18257200146512 37-5209SP 18257200146529 37-5210SP 18257200146536 37-5211SP 18257200146543 37-5212SP 18257200146550. 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-0891-2026&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-0891-2026&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-0891-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0891-2026 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-0891-2026&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-0891-2026&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-0891-2026/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-0891-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0891-2026",
            "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 Lots/ UDI: 37-3106SP 18257200030590 37-3107SP 18257200030613 37-3108SP 18257200030637 37-3109SP 18257200030651 37-3110SP 18257200030675 37-3111SP 18257200030699 37-3112SP 18257200030712 37-3113SP 18257200030736 37-3114SP 18257200030750 37-3006SP 18257200030415 37-3007SP 18257200030439 37-3008SP 18257200030453 37-3009SP 18257200030477 37-3010SP 18257200030491 37-3011SP 18257200030514 37-3012SP 18257200030538 37-3013SP 18257200030552 37-3014SP 18257200030576 37-3207SP 18257200146352 37-3208SP 18257200146369 37-3209SP 18257200146376 37-3210SP 18257200146383 37-3211SP 18257200146390 37-3212SP 18257200146406 37-4106SP 18257200030958 37-4107SP 18257200030972 37-4108SP 18257200030996 37-4109SP 18257200031016 37-4110SP 18257200031030 37-4111SP 18257200031054 37-4112SP 18257200031078 37-4113SP 18257200031092 37-4114SP 18257200031115 37-4006SP 18257200030774 37-4007SP 18257200030798 Part Number GTIN 37-4008SP 18257200030811 37-4009SP 18257200030835 37-4010SP 18257200030859 37-4011SP 18257200030873 37-4012SP 18257200030897 37-4013SP 18257200030910 37-4014SP 18257200030934 37-4207SP 18257200146420 37-4208SP 18257200146437 37-4209SP 18257200146444 37-4210SP 18257200146451 37-4211SP 18257200146468 37-4212SP 18257200146475 37-5106SP 18257200031313 37-5107SP 18257200031337 37-5108SP 18257200031351 37-5109SP 18257200031375 37-5110SP 18257200031399 37-5111SP 18257200031412 37-5112SP 18257200031436 37-5113SP 18257200031450 37-5114SP 18257200031474 37-5006SP 18257200031139 37-5007SP 18257200031153 37-5008SP 18257200031177 37-5009SP 18257200031191 37-5010SP 18257200031214 37-5011SP 18257200031238 37-5012SP 18257200031252 37-5013SP 18257200031276 37-5014SP 18257200031290 37-5207SP 18257200146505 37-5208SP 18257200146512 37-5209SP 18257200146529 37-5210SP 18257200146536 37-5211SP 18257200146543 37-5212SP 18257200146550",
            "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"
          }
        }
      ]
    }
  ]
}