{
  "@context": {
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1166-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Novation XLE  Item Number / Product Description:  140-22-70\tNV EHXL NTL LNR G00 22MM  140-28-50\tNV EHXLNTRL LNR G0 28MM  140-28-51\tNV EHXLNTRL LNR G1 28MM  140-28-52\tNV EHXL NTRL LNR G228MM  140-32-51\tNV EHXL NTRL LNR G132MM  140-32-52\tNV EHXL NTRL LNR G232MM  140-32-53\tNV EHXL NTRL LNR G332MM  140-32-54\tNV EHXLNTRL LNR G4 32MM  140-32-55\tNV EHXLNTRL LNR G5 32MM  140-36-52\tNV EHXLNTRL LNR G2 36MM  140-36-53\tNV EHXL NTRL LNR G336MM  140-36-54\tNV EHXLNTRL LNR G4 36MM  140-36-55\tNV EHXLNTRL LNR G5 36MM  140-40-53\tNV EHXLNTRL LNR G3 40MM  140-40-54\tNV EHXLNTRL LNR G4 40MM  140-40-55\tNV EHXLNTRL LNR G5 40MM  142-22-68\tNV EHXL ALPLNR G00 22MM  142-22-70\tNV EHXL LIPLNR G00 22MM  142-28-50\tNV EHXL LIP LNR G0 28MM  142-28-51\tNV EHXL LIP LNR G1 28MM  142-28-52\tNV EHXL LIP LNR G2 28MM  142-28-60\tNV EHXL ALIPLNR G0 28MM  142-28-61\tNV EHXL ALIP LNR G1 28MM  142-28-62\tNV EHXL ALIP LNR G2 28MM  142-32-51\tNV EHXL LIP LNR G1 32MM  142-32-52\tNV EHXL LIP LNR G2 32MM  142-32-53\tNV EHXL LIP LNR G3 32MM  142-32-54\tNV EHXL LIP LNR G4 32MM  142-32-55\tNV EHXL LIP LNR G5 32MM  142-32-61\tNV EHXL ALIP LNR G1 32MM  142-32-62\tNV EHXL ALIP LNR G2 32MM  142-32-63\tNV EHXL ALIP LNR G3 32MM  142-32-64\tNV EHXL ALIP LNR G4 32MM  142-32-65\tNV EHXL ALIP LNR G5 32MM  142-36-52\tNV EHXL LIP LNR G2 36MM  142-36-53\tNV EHXL LIP LNR G3 36MM  142-36-54\tNV EHXL LIP LNR G4 36MM  142-36-55\tNV EHXL LIP LNR G5 36MM  142-36-62\tNV EHXL ALIP LNR G2 36MM  142-36-63\tNV EHXL ALIP LNR G3 36MM  142-36-64\tNV EHXL ALIP LNR G4 36MM  142-36-65\tNV EHXL ALIP LNR G5 36MM  142-40-53\tNV EHXL LIP LNR G3 40MM  142-40-54\tNV EHXL LIP LNR G4 40MM  142-40-55\tNV EHXL LIP LNR G5 40MM  142-40-63\tNV EHXL ALIP LNR G3 40MM  142-40-64\tNV EHXL ALIP LNR G4 40MM  142-40-65\tNV EHXL ALIP LNR G5 40MM  146-22-70\tNV EHXL LATLNR G00 22MM  146-28-51\tNV EHXL LAT LNR G1 28MM  146-32-51\tNV EHXL LAT LNR G1 32MM  146-32-52\tNV EHXL LAT LNR G2 32MM  146-32-53\tNV EHXL LAT LNR G3 32MM  146-32-54\tNV EHXL LAT LNR G4 32MM  146-32-55\tNV EHXL LAT LNR G5 32MM  146-36-52\tNV EHXL LAT LNR G2 36MM  146-36-53\tNV EHXL LAT LNR G3 36MM  146-36-54\tNV EHXL LAT LNR G4 36MM  146-36-55\tNV EHXL LAT LNR G5 36MM  146-40-53\tNV EHXL LAT LNR G3 40MM  146-40-54\tNV EHXL LAT LNR G4 40MM  146-40-55\tNV EHXL LAT LNR G5 40MM  148-32-51\tNV EHXL 10¿ LNR G1 32MM  148-36-52\tNV EHXL 10¿ LNR G2 36MM  148-36-53\tNV EHXL 10¿ LNR G3 36MM  148-36-54\tNV EHXL 10¿ LNR G4 36MM  148-36-55\tNV EHXL 10¿ LNR G5 36MM  148-40-53\tNV EHXL 10¿ LNR G3 40MM  148-40-54\tNV EHXL 10¿ LNR G4 40MM  148-40-55\tNV EHXL 10¿ LNR G5 40MM    All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.",
  "description": "FDA recall Z-1166-2025 — Exactech, Inc. is recalling Novation XLE  Item Number / Product Description:  140-22-70\tNV EHXL NTL LNR G00 22MM  140-28-50\tNV EHXLNTRL LNR G0 28MM  140-28-51\tNV EHXLNTRL LNR G1 28MM  140-28-52\tNV EHXL NTRL LNR G228MM  140-32-51\tNV EHXL NTRL LNR G132MM  140-32-52\tNV EHXL NTRL LNR G232MM  140-32-53\tNV EHXL NTRL LNR G332MM  140-32-54\tNV EHXLNTRL LNR G4 32MM  140-32-55\tNV EHXLNTRL LNR G5 32MM  140-36-52\tNV EHXLNTRL LNR G2 36MM  140-36-53\tNV EHXL NTRL LNR G336MM  140-36-54\tNV EHXLNTRL LNR G4 36MM  140-36-55\tNV EHXLNTRL LNR G5 36MM  140-40-53\tNV EHXLNTRL LNR G3 40MM  140-40-54\tNV EHXLNTRL LNR G4 40MM  140-40-55\tNV EHXLNTRL LNR G5 40MM  142-22-68\tNV EHXL ALPLNR G00 22MM  142-22-70\tNV EHXL LIPLNR G00 22MM  142-28-50\tNV EHXL LIP LNR G0 28MM  142-28-51\tNV EHXL LIP LNR G1 28MM  142-28-52\tNV EHXL LIP LNR G2 28MM  142-28-60\tNV EHXL ALIPLNR G0 28MM  142-28-61\tNV EHXL ALIP LNR G1 28MM  142-28-62\tNV EHXL ALIP LNR G2 28MM  142-32-51\tNV EHXL LIP LNR G1 32MM  142-32-52\tNV EHXL LIP LNR G2 32MM  142-32-53\tNV EHXL LIP LNR G3 32MM  142-32-54\tNV EHXL LIP LNR G4 32MM  142-32-55\tNV EHXL LIP LNR G5 32MM  142-32-61\tNV EHXL ALIP LNR G1 32MM  142-32-62\tNV EHXL ALIP LNR G2 32MM  142-32-63\tNV EHXL ALIP LNR G3 32MM  142-32-64\tNV EHXL ALIP LNR G4 32MM  142-32-65\tNV EHXL ALIP LNR G5 32MM  142-36-52\tNV EHXL LIP LNR G2 36MM  142-36-53\tNV EHXL LIP LNR G3 36MM  142-36-54\tNV EHXL LIP LNR G4 36MM  142-36-55\tNV EHXL LIP LNR G5 36MM  142-36-62\tNV EHXL ALIP LNR G2 36MM  142-36-63\tNV EHXL ALIP LNR G3 36MM  142-36-64\tNV EHXL ALIP LNR G4 36MM  142-36-65\tNV EHXL ALIP LNR G5 36MM  142-40-53\tNV EHXL LIP LNR G3 40MM  142-40-54\tNV EHXL LIP LNR G4 40MM  142-40-55\tNV EHXL LIP LNR G5 40MM  142-40-63\tNV EHXL ALIP LNR G3 40MM  142-40-64\tNV EHXL ALIP LNR G4 40MM  142-40-65\tNV EHXL ALIP LNR G5 40MM  146-22-70\tNV EHXL LATLNR G00 22MM  146-28-51\tNV EHXL LAT LNR G1 28MM  146-32-51\tNV EHXL LAT LNR G1 32MM  146-32-52\tNV EHXL LAT LNR G2 32MM  146-32-53\tNV EHXL LAT LNR G3 32MM  146-32-54\tNV EHXL LAT LNR G4 32MM  146-32-55\tNV EHXL LAT LNR G5 32MM  146-36-52\tNV EHXL LAT LNR G2 36MM  146-36-53\tNV EHXL LAT LNR G3 36MM  146-36-54\tNV EHXL LAT LNR G4 36MM  146-36-55\tNV EHXL LAT LNR G5 36MM  146-40-53\tNV EHXL LAT LNR G3 40MM  146-40-54\tNV EHXL LAT LNR G4 40MM  146-40-55\tNV EHXL LAT LNR G5 40MM  148-32-51\tNV EHXL 10¿ LNR G1 32MM  148-36-52\tNV EHXL 10¿ LNR G2 36MM  148-36-53\tNV EHXL 10¿ LNR G3 36MM  148-36-54\tNV EHXL 10¿ LNR G4 36MM  148-36-55\tNV EHXL 10¿ LNR G5 36MM  148-40-53\tNV EHXL 10¿ LNR G3 40MM  148-40-54\tNV EHXL 10¿ LNR G4 40MM  148-40-55\tNV EHXL 10¿ LNR G5 40MM    All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "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-1166-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Novation XLE  Item Number / Product Description:  140-22-70\tNV EHXL NTL LNR G00 22MM  140-28-50\tNV EHXLNTRL LNR G0 28MM  140-28-51\tNV EHXLNTRL LNR G1 28MM  140-28-52\tNV EHXL NTRL LNR G228MM  140-32-51\tNV EHXL NTRL LNR G132MM  140-32-52\tNV EHXL NTRL LNR G232MM  140-32-53\tNV EHXL NTRL LNR G332MM  140-32-54\tNV EHXLNTRL LNR G4 32MM  140-32-55\tNV EHXLNTRL LNR G5 32MM  140-36-52\tNV EHXLNTRL LNR G2 36MM  140-36-53\tNV EHXL NTRL LNR G336MM  140-36-54\tNV EHXLNTRL LNR G4 36MM  140-36-55\tNV EHXLNTRL LNR G5 36MM  140-40-53\tNV EHXLNTRL LNR G3 40MM  140-40-54\tNV EHXLNTRL LNR G4 40MM  140-40-55\tNV EHXLNTRL LNR G5 40MM  142-22-68\tNV EHXL ALPLNR G00 22MM  142-22-70\tNV EHXL LIPLNR G00 22MM  142-28-50\tNV EHXL LIP LNR G0 28MM  142-28-51\tNV EHXL LIP LNR G1 28MM  142-28-52\tNV EHXL LIP LNR G2 28MM  142-28-60\tNV EHXL ALIPLNR G0 28MM  142-28-61\tNV EHXL ALIP LNR G1 28MM  142-28-62\tNV EHXL ALIP LNR G2 28MM  142-32-51\tNV EHXL LIP LNR G1 32MM  142-32-52\tNV EHXL LIP LNR G2 32MM  142-32-53\tNV EHXL LIP LNR G3 32MM  142-32-54\tNV EHXL LIP LNR G4 32MM  142-32-55\tNV EHXL LIP LNR G5 32MM  142-32-61\tNV EHXL ALIP LNR G1 32MM  142-32-62\tNV EHXL ALIP LNR G2 32MM  142-32-63\tNV EHXL ALIP LNR G3 32MM  142-32-64\tNV EHXL ALIP LNR G4 32MM  142-32-65\tNV EHXL ALIP LNR G5 32MM  142-36-52\tNV EHXL LIP LNR G2 36MM  142-36-53\tNV EHXL LIP LNR G3 36MM  142-36-54\tNV EHXL LIP LNR G4 36MM  142-36-55\tNV EHXL LIP LNR G5 36MM  142-36-62\tNV EHXL ALIP LNR G2 36MM  142-36-63\tNV EHXL ALIP LNR G3 36MM  142-36-64\tNV EHXL ALIP LNR G4 36MM  142-36-65\tNV EHXL ALIP LNR G5 36MM  142-40-53\tNV EHXL LIP LNR G3 40MM  142-40-54\tNV EHXL LIP LNR G4 40MM  142-40-55\tNV EHXL LIP LNR G5 40MM  142-40-63\tNV EHXL ALIP LNR G3 40MM  142-40-64\tNV EHXL ALIP LNR G4 40MM  142-40-65\tNV EHXL ALIP LNR G5 40MM  146-22-70\tNV EHXL LATLNR G00 22MM  146-28-51\tNV EHXL LAT LNR G1 28MM  146-32-51\tNV EHXL LAT LNR G1 32MM  146-32-52\tNV EHXL LAT LNR G2 32MM  146-32-53\tNV EHXL LAT LNR G3 32MM  146-32-54\tNV EHXL LAT LNR G4 32MM  146-32-55\tNV EHXL LAT LNR G5 32MM  146-36-52\tNV EHXL LAT LNR G2 36MM  146-36-53\tNV EHXL LAT LNR G3 36MM  146-36-54\tNV EHXL LAT LNR G4 36MM  146-36-55\tNV EHXL LAT LNR G5 36MM  146-40-53\tNV EHXL LAT LNR G3 40MM  146-40-54\tNV EHXL LAT LNR G4 40MM  146-40-55\tNV EHXL LAT LNR G5 40MM  148-32-51\tNV EHXL 10¿ LNR G1 32MM  148-36-52\tNV EHXL 10¿ LNR G2 36MM  148-36-53\tNV EHXL 10¿ LNR G3 36MM  148-36-54\tNV EHXL 10¿ LNR G4 36MM  148-36-55\tNV EHXL 10¿ LNR G5 36MM  148-40-53\tNV EHXL 10¿ LNR G3 40MM  148-40-54\tNV EHXL 10¿ LNR G4 40MM  148-40-55\tNV EHXL 10¿ LNR G5 40MM    All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Exactech, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1166-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1166-2025: Exactech, Inc. is recalling Novation XLE  Item Number / Product Description:  140-22-70\tNV EHXL NTL LNR G00 22MM  140-28-50\tNV EHXLNTRL LNR G0 28MM  140-28-51\tNV EHXLNTRL LNR G1 28MM  140-28-52\tNV EHXL NTRL LNR G228MM  140-32-51\tNV EHXL NTRL LNR G132MM  140-32-52\tNV EHXL NTRL LNR G232MM  140-32-53\tNV EHXL NTRL LNR G332MM  140-32-54\tNV EHXLNTRL LNR G4 32MM  140-32-55\tNV EHXLNTRL LNR G5 32MM  140-36-52\tNV EHXLNTRL LNR G2 36MM  140-36-53\tNV EHXL NTRL LNR G336MM  140-36-54\tNV EHXLNTRL LNR G4 36MM  140-36-55\tNV EHXLNTRL LNR G5 36MM  140-40-53\tNV EHXLNTRL LNR G3 40MM  140-40-54\tNV EHXLNTRL LNR G4 40MM  140-40-55\tNV EHXLNTRL LNR G5 40MM  142-22-68\tNV EHXL ALPLNR G00 22MM  142-22-70\tNV EHXL LIPLNR G00 22MM  142-28-50\tNV EHXL LIP LNR G0 28MM  142-28-51\tNV EHXL LIP LNR G1 28MM  142-28-52\tNV EHXL LIP LNR G2 28MM  142-28-60\tNV EHXL ALIPLNR G0 28MM  142-28-61\tNV EHXL ALIP LNR G1 28MM  142-28-62\tNV EHXL ALIP LNR G2 28MM  142-32-51\tNV EHXL LIP LNR G1 32MM  142-32-52\tNV EHXL LIP LNR G2 32MM  142-32-53\tNV EHXL LIP LNR G3 32MM  142-32-54\tNV EHXL LIP LNR G4 32MM  142-32-55\tNV EHXL LIP LNR G5 32MM  142-32-61\tNV EHXL ALIP LNR G1 32MM  142-32-62\tNV EHXL ALIP LNR G2 32MM  142-32-63\tNV EHXL ALIP LNR G3 32MM  142-32-64\tNV EHXL ALIP LNR G4 32MM  142-32-65\tNV EHXL ALIP LNR G5 32MM  142-36-52\tNV EHXL LIP LNR G2 36MM  142-36-53\tNV EHXL LIP LNR G3 36MM  142-36-54\tNV EHXL LIP LNR G4 36MM  142-36-55\tNV EHXL LIP LNR G5 36MM  142-36-62\tNV EHXL ALIP LNR G2 36MM  142-36-63\tNV EHXL ALIP LNR G3 36MM  142-36-64\tNV EHXL ALIP LNR G4 36MM  142-36-65\tNV EHXL ALIP LNR G5 36MM  142-40-53\tNV EHXL LIP LNR G3 40MM  142-40-54\tNV EHXL LIP LNR G4 40MM  142-40-55\tNV EHXL LIP LNR G5 40MM  142-40-63\tNV EHXL ALIP LNR G3 40MM  142-40-64\tNV EHXL ALIP LNR G4 40MM  142-40-65\tNV EHXL ALIP LNR G5 40MM  146-22-70\tNV EHXL LATLNR G00 22MM  146-28-51\tNV EHXL LAT LNR G1 28MM  146-32-51\tNV EHXL LAT LNR G1 32MM  146-32-52\tNV EHXL LAT LNR G2 32MM  146-32-53\tNV EHXL LAT LNR G3 32MM  146-32-54\tNV EHXL LAT LNR G4 32MM  146-32-55\tNV EHXL LAT LNR G5 32MM  146-36-52\tNV EHXL LAT LNR G2 36MM  146-36-53\tNV EHXL LAT LNR G3 36MM  146-36-54\tNV EHXL LAT LNR G4 36MM  146-36-55\tNV EHXL LAT LNR G5 36MM  146-40-53\tNV EHXL LAT LNR G3 40MM  146-40-54\tNV EHXL LAT LNR G4 40MM  146-40-55\tNV EHXL LAT LNR G5 40MM  148-32-51\tNV EHXL 10¿ LNR G1 32MM  148-36-52\tNV EHXL 10¿ LNR G2 36MM  148-36-53\tNV EHXL 10¿ LNR G3 36MM  148-36-54\tNV EHXL 10¿ LNR G4 36MM  148-36-55\tNV EHXL 10¿ LNR G5 36MM  148-40-53\tNV EHXL 10¿ LNR G3 40MM  148-40-54\tNV EHXL 10¿ LNR G4 40MM  148-40-55\tNV EHXL 10¿ LNR G5 40MM    All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.",
      "text": "The FDA logged enforcement record Z-1166-2025: Exactech, Inc. is voluntarily recalling Novation XLE  Item Number / Product Description:  140-22-70\tNV EHXL NTL LNR G00 22MM  140-28-50\tNV EHXLNTRL LNR G0 28MM  140-28-51\tNV EHXLNTRL LNR G1 28MM  140-28-52\tNV EHXL NTRL LNR G228MM  140-32-51\tNV EHXL NTRL LNR G132MM  140-32-52\tNV EHXL NTRL LNR G232MM  140-32-53\tNV EHXL NTRL LNR G332MM  140-32-54\tNV EHXLNTRL LNR G4 32MM  140-32-55\tNV EHXLNTRL LNR G5 32MM  140-36-52\tNV EHXLNTRL LNR G2 36MM  140-36-53\tNV EHXL NTRL LNR G336MM  140-36-54\tNV EHXLNTRL LNR G4 36MM  140-36-55\tNV EHXLNTRL LNR G5 36MM  140-40-53\tNV EHXLNTRL LNR G3 40MM  140-40-54\tNV EHXLNTRL LNR G4 40MM  140-40-55\tNV EHXLNTRL LNR G5 40MM  142-22-68\tNV EHXL ALPLNR G00 22MM  142-22-70\tNV EHXL LIPLNR G00 22MM  142-28-50\tNV EHXL LIP LNR G0 28MM  142-28-51\tNV EHXL LIP LNR G1 28MM  142-28-52\tNV EHXL LIP LNR G2 28MM  142-28-60\tNV EHXL ALIPLNR G0 28MM  142-28-61\tNV EHXL ALIP LNR G1 28MM  142-28-62\tNV EHXL ALIP LNR G2 28MM  142-32-51\tNV EHXL LIP LNR G1 32MM  142-32-52\tNV EHXL LIP LNR G2 32MM  142-32-53\tNV EHXL LIP LNR G3 32MM  142-32-54\tNV EHXL LIP LNR G4 32MM  142-32-55\tNV EHXL LIP LNR G5 32MM  142-32-61\tNV EHXL ALIP LNR G1 32MM  142-32-62\tNV EHXL ALIP LNR G2 32MM  142-32-63\tNV EHXL ALIP LNR G3 32MM  142-32-64\tNV EHXL ALIP LNR G4 32MM  142-32-65\tNV EHXL ALIP LNR G5 32MM  142-36-52\tNV EHXL LIP LNR G2 36MM  142-36-53\tNV EHXL LIP LNR G3 36MM  142-36-54\tNV EHXL LIP LNR G4 36MM  142-36-55\tNV EHXL LIP LNR G5 36MM  142-36-62\tNV EHXL ALIP LNR G2 36MM  142-36-63\tNV EHXL ALIP LNR G3 36MM  142-36-64\tNV EHXL ALIP LNR G4 36MM  142-36-65\tNV EHXL ALIP LNR G5 36MM  142-40-53\tNV EHXL LIP LNR G3 40MM  142-40-54\tNV EHXL LIP LNR G4 40MM  142-40-55\tNV EHXL LIP LNR G5 40MM  142-40-63\tNV EHXL ALIP LNR G3 40MM  142-40-64\tNV EHXL ALIP LNR G4 40MM  142-40-65\tNV EHXL ALIP LNR G5 40MM  146-22-70\tNV EHXL LATLNR G00 22MM  146-28-51\tNV EHXL LAT LNR G1 28MM  146-32-51\tNV EHXL LAT LNR G1 32MM  146-32-52\tNV EHXL LAT LNR G2 32MM  146-32-53\tNV EHXL LAT LNR G3 32MM  146-32-54\tNV EHXL LAT LNR G4 32MM  146-32-55\tNV EHXL LAT LNR G5 32MM  146-36-52\tNV EHXL LAT LNR G2 36MM  146-36-53\tNV EHXL LAT LNR G3 36MM  146-36-54\tNV EHXL LAT LNR G4 36MM  146-36-55\tNV EHXL LAT LNR G5 36MM  146-40-53\tNV EHXL LAT LNR G3 40MM  146-40-54\tNV EHXL LAT LNR G4 40MM  146-40-55\tNV EHXL LAT LNR G5 40MM  148-32-51\tNV EHXL 10¿ LNR G1 32MM  148-36-52\tNV EHXL 10¿ LNR G2 36MM  148-36-53\tNV EHXL 10¿ LNR G3 36MM  148-36-54\tNV EHXL 10¿ LNR G4 36MM  148-36-55\tNV EHXL 10¿ LNR G5 36MM  148-40-53\tNV EHXL 10¿ LNR G3 40MM  148-40-54\tNV EHXL 10¿ LNR G4 40MM  148-40-55\tNV EHXL 10¿ LNR G5 40MM    All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. — reason: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-31. Affected lots/codes: Item Number / Product Description/ UDI-DI code: 140-22-70 NV EHXL NTL LNR G00 22MM 10885862537225 140-28-50 NV EHXLNTRL LNR G0 28MM 10885862537232 140-28-51 NV EHXLNTRL LNR G1 28MM 10885862537249 140-28-52 NV EHXL NTRL LNR G228MM 10885862537256 140-32-51 NV EHXL NTRL LNR G132MM 10885862537263 Serial Numbers: 6594943 6970850 6595376 6595380 6858220 6858230 6973123 6594924 6970840 6595383 6595385 6595381 6970835 6970838 6970842 6595922 6510276 6973139  140-32-52 NV EHXL NTRL LNR G232MM 10885862537270 140-32-53 NV EHXL NTRL LNR G332MM 10885862537287 140-32-54 NV EHXLNTRL LNR G4 32MM 10885862537294 140-32-55 NV EHXLNTRL LNR G5 32MM 10885862537300 140-36-52 NV EHXLNTRL LNR G2 36MM 10885862537317 Serial Numbers: 6558356 6422337 6631675 6504196 6631677 6631695 6631712 6844304 6631689 6631699 6631725 6558360 6844285 6844298 6844281 6348961 6504177 6504195 6504202 6504204 6631686 6844321  140-36-53 NV EHXL NTRL LNR G336MM 10885862537324 Serial Numbers: 6600076 6600101 6600054 6600057 6600093  140-36-54 NV EHXLNTRL LNR G4 36MM 10885862537331 140-36-55 NV EHXLNTRL LNR G5 36MM 10885862537348 140-40-53 NV EHXLNTRL LNR G3 40MM 10885862537355 Serial Numbers: 6510314 6510327  140-40-54 NV EHXLNTRL LNR G4 40MM 10885862537362 140-40-55 NV EHXLNTRL LNR G5 40MM 10885862537379 142-22-68 NV EHXL ALPLNR G00 22MM 10885862537546 142-22-70 NV EHXL LIPLNR G00 22MM 10885862537386 142-28-50 NV EHXL LIP LNR G0 28MM 10885862537393 142-28-51 NV EHXL LIP LNR G1 28MM 10885862537409 142-28-52 NV EHXL LIP LNR G2 28MM 10885862537416 142-28-60 NV EHXL ALIPLNR G0 28MM 10885862537553 142-28-61 NV EHXL ALIP LNR G1 28MM 10885862537560 142-28-62 NV EHXL ALIP LNR G2 28MM 10885862537577 142-32-51 NV EHXL LIP LNR G1 32MM 10885862537423 142-32-52 NV EHXL LIP LNR G2 32MM 10885862537430 142-32-53 NV EHXL LIP LNR G3 32MM 10885862537447 142-32-54 NV EHXL LIP LNR G4 32MM 10885862537454 142-32-55 NV EHXL LIP LNR G5 32MM 10885862537461 142-32-61 NV EHXL ALIP LNR G1 32MM 10885862537584 Serial Numbers: 7040076 6842549 6554448 6596005 6554464 6554458 6866177 6596019 6554457 6595993 6503270  142-32-62 NV EHXL ALIP LNR G2 32MM 10885862537591 142-32-63 NV EHXL ALIP LNR G3 32MM 10885862537607 142-32-64 NV EHXL ALIP LNR G4 32MM 10885862537614 142-32-65 NV EHXL ALIP LNR G5 32MM 10885862537621 142-36-52 NV EHXL LIP LNR G2 36MM 10885862537478 142-36-53 NV EHXL LIP LNR G3 36MM 10885862537485 142-36-54 NV EHXL LIP LNR G4 36MM 10885862537492 142-36-55 NV EHXL LIP LNR G5 36MM 10885862537508 142-36-62 NV EHXL ALIP LNR G2 36MM 10885862537638 Serial Numbers: 6831997 6679288 6831980 7032226 6679275 6831983 6335167 6832001 6555554 7032248 6679286 6679321 6831992 6927281  142-36-63 NV EHXL ALIP LNR G3 36MM 10885862537645 142-36-64 NV EHXL ALIP LNR G4 36MM 10885862537652 142-36-65 NV EHXL ALIP LNR G5 36MM 10885862537669 142-40-53 NV EHXL LIP LNR G3 40MM 10885862537515 142-40-54 NV EHXL LIP LNR G4 40MM 10885862537522 142-40-55 NV EHXL LIP LNR G5 40MM 10885862537539 142-40-63 NV EHXL ALIP LNR G3 40MM 10885862537676 Serial Numbers: 6452595  142-40-64 NV EHXL ALIP LNR G4 40MM 10885862537683 142-40-65 NV EHXL ALIP LNR G5 40MM 10885862537690 146-22-70 NV EHXL LATLNR G00 22MM 10885862537751 146-28-51 NV EHXL LAT LNR G1 28MM 10885862537768 146-32-51 NV EHXL LAT LNR G1 32MM 10885862537775 146-32-52 NV EHXL LAT LNR G2 32MM 10885862537782 146-32-53 NV EHXL LAT LNR G3 32MM 10885862537799 146-32-54 NV EHXL LAT LNR G4 32MM 10885862537805 146-32-55 NV EHXL LAT LNR G5 32MM 10885862537812 146-36-52 NV EHXL LAT LNR G2 36MM 10885862537829 146-36-53 NV EHXL LAT LNR G3 36MM 10885862537836 146-36-54 NV EHXL LAT LNR G4 36MM 10885862537843 146-36-55 NV EHXL LAT LNR G5 36MM 10885862537850 146-40-53 NV EHXL LAT LNR G3 40MM 10885862537867 Serial Numbers: 6602255 6602261 6602265 6602268 6602269 6602270 6602272 6602256 6602263 6602267 6602277 6602257 6602258 6602273  146-40-54 NV EHXL LAT LNR G4 40MM 10885862537874 146-40-55 NV EHXL LAT LNR G5 40MM 10885862537881 148-32-51 NV EHXL 10¿ LNR G1 32MM 10885862537898 148-36-52 NV EHXL 10¿ LNR G2 36MM 10885862537904 148-36-53 NV EHXL 10¿ LNR G3 36MM 10885862537911 148-36-54 NV EHXL 10¿ LNR G4 36MM 10885862537928 148-36-55 NV EHXL 10¿ LNR G5 36MM 10885862537935 148-40-53 NV EHXL 10¿ LNR G3 40MM 10885862537942 148-40-54 NV EHXL 10¿ LNR G4 40MM 10885862537959 148-40-55 NV EHXL 10¿ LNR G5 40MM 10885862537966. 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-1166-2025&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-1166-2025&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-1166-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1166-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "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-1166-2025&lang=eng",
        "value": "Class II",
        "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-1166-2025&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-1166-2025/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-1166-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1166-2025",
            "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 II",
            "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": "Exactech, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-12-31",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Item Number / Product Description/ UDI-DI code: 140-22-70 NV EHXL NTL LNR G00 22MM 10885862537225 140-28-50 NV EHXLNTRL LNR G0 28MM 10885862537232 140-28-51 NV EHXLNTRL LNR G1 28MM 10885862537249 140-28-52 NV EHXL NTRL LNR G228MM 10885862537256 140-32-51 NV EHXL NTRL LNR G132MM 10885862537263 Serial Numbers: 6594943 6970850 6595376 6595380 6858220 6858230 6973123 6594924 6970840 6595383 6595385 6595381 6970835 6970838 6970842 6595922 6510276 6973139  140-32-52 NV EHXL NTRL LNR G232MM 10885862537270 140-32-53 NV EHXL NTRL LNR G332MM 10885862537287 140-32-54 NV EHXLNTRL LNR G4 32MM 10885862537294 140-32-55 NV EHXLNTRL LNR G5 32MM 10885862537300 140-36-52 NV EHXLNTRL LNR G2 36MM 10885862537317 Serial Numbers: 6558356 6422337 6631675 6504196 6631677 6631695 6631712 6844304 6631689 6631699 6631725 6558360 6844285 6844298 6844281 6348961 6504177 6504195 6504202 6504204 6631686 6844321  140-36-53 NV EHXL NTRL LNR G336MM 10885862537324 Serial Numbers: 6600076 6600101 6600054 6600057 6600093  140-36-54 NV EHXLNTRL LNR G4 36MM 10885862537331 140-36-55 NV EHXLNTRL LNR G5 36MM 10885862537348 140-40-53 NV EHXLNTRL LNR G3 40MM 10885862537355 Serial Numbers: 6510314 6510327  140-40-54 NV EHXLNTRL LNR G4 40MM 10885862537362 140-40-55 NV EHXLNTRL LNR G5 40MM 10885862537379 142-22-68 NV EHXL ALPLNR G00 22MM 10885862537546 142-22-70 NV EHXL LIPLNR G00 22MM 10885862537386 142-28-50 NV EHXL LIP LNR G0 28MM 10885862537393 142-28-51 NV EHXL LIP LNR G1 28MM 10885862537409 142-28-52 NV EHXL LIP LNR G2 28MM 10885862537416 142-28-60 NV EHXL ALIPLNR G0 28MM 10885862537553 142-28-61 NV EHXL ALIP LNR G1 28MM 10885862537560 142-28-62 NV EHXL ALIP LNR G2 28MM 10885862537577 142-32-51 NV EHXL LIP LNR G1 32MM 10885862537423 142-32-52 NV EHXL LIP LNR G2 32MM 10885862537430 142-32-53 NV EHXL LIP LNR G3 32MM 10885862537447 142-32-54 NV EHXL LIP LNR G4 32MM 10885862537454 142-32-55 NV EHXL LIP LNR G5 32MM 10885862537461 142-32-61 NV EHXL ALIP LNR G1 32MM 10885862537584 Serial Numbers: 7040076 6842549 6554448 6596005 6554464 6554458 6866177 6596019 6554457 6595993 6503270  142-32-62 NV EHXL ALIP LNR G2 32MM 10885862537591 142-32-63 NV EHXL ALIP LNR G3 32MM 10885862537607 142-32-64 NV EHXL ALIP LNR G4 32MM 10885862537614 142-32-65 NV EHXL ALIP LNR G5 32MM 10885862537621 142-36-52 NV EHXL LIP LNR G2 36MM 10885862537478 142-36-53 NV EHXL LIP LNR G3 36MM 10885862537485 142-36-54 NV EHXL LIP LNR G4 36MM 10885862537492 142-36-55 NV EHXL LIP LNR G5 36MM 10885862537508 142-36-62 NV EHXL ALIP LNR G2 36MM 10885862537638 Serial Numbers: 6831997 6679288 6831980 7032226 6679275 6831983 6335167 6832001 6555554 7032248 6679286 6679321 6831992 6927281  142-36-63 NV EHXL ALIP LNR G3 36MM 10885862537645 142-36-64 NV EHXL ALIP LNR G4 36MM 10885862537652 142-36-65 NV EHXL ALIP LNR G5 36MM 10885862537669 142-40-53 NV EHXL LIP LNR G3 40MM 10885862537515 142-40-54 NV EHXL LIP LNR G4 40MM 10885862537522 142-40-55 NV EHXL LIP LNR G5 40MM 10885862537539 142-40-63 NV EHXL ALIP LNR G3 40MM 10885862537676 Serial Numbers: 6452595  142-40-64 NV EHXL ALIP LNR G4 40MM 10885862537683 142-40-65 NV EHXL ALIP LNR G5 40MM 10885862537690 146-22-70 NV EHXL LATLNR G00 22MM 10885862537751 146-28-51 NV EHXL LAT LNR G1 28MM 10885862537768 146-32-51 NV EHXL LAT LNR G1 32MM 10885862537775 146-32-52 NV EHXL LAT LNR G2 32MM 10885862537782 146-32-53 NV EHXL LAT LNR G3 32MM 10885862537799 146-32-54 NV EHXL LAT LNR G4 32MM 10885862537805 146-32-55 NV EHXL LAT LNR G5 32MM 10885862537812 146-36-52 NV EHXL LAT LNR G2 36MM 10885862537829 146-36-53 NV EHXL LAT LNR G3 36MM 10885862537836 146-36-54 NV EHXL LAT LNR G4 36MM 10885862537843 146-36-55 NV EHXL LAT LNR G5 36MM 10885862537850 146-40-53 NV EHXL LAT LNR G3 40MM 10885862537867 Serial Numbers: 6602255 6602261 6602265 6602268 6602269 6602270 6602272 6602256 6602263 6602267 6602277 6602257 6602258 6602273  146-40-54 NV EHXL LAT LNR G4 40MM 10885862537874 146-40-55 NV EHXL LAT LNR G5 40MM 10885862537881 148-32-51 NV EHXL 10¿ LNR G1 32MM 10885862537898 148-36-52 NV EHXL 10¿ LNR G2 36MM 10885862537904 148-36-53 NV EHXL 10¿ LNR G3 36MM 10885862537911 148-36-54 NV EHXL 10¿ LNR G4 36MM 10885862537928 148-36-55 NV EHXL 10¿ LNR G5 36MM 10885862537935 148-40-53 NV EHXL 10¿ LNR G3 40MM 10885862537942 148-40-54 NV EHXL 10¿ LNR G4 40MM 10885862537959 148-40-55 NV EHXL 10¿ LNR G5 40MM 10885862537966",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA  O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}