{
  "@context": {
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    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "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-0017-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N;  IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N;  IMPLANT EPIKUT PLUS MT16  3,5X13,0MM, REF: ILM 3513N;  IMPLANT EPIKUT PLUS MT16  3,5X15,0MM, REF: ILM 3515N;  IMPLANT EPIKUT PLUS MT16  3,8X10,0MM, REF: ILM 3810N;  IMPLANT CM16  3,8 X 11MM, REF: ILM 3811N;  IMPLANT EPIKUT PLUS MT16  3,8X15,0MM, REF: ILM 3815N;  IMPLANT EPIKUT PLUS MT16  4,0X10,0MM, REF: ILM 4010N;  IMPLANT EPIKUT PLUS MT16  4,0X11,5MM, REF: ILM 4011N;  IMPLANT EPIKUT PLUS MT16  4,0X13,0MM, REF: ILM 4013N;  IMP EPIKUT PLUS LONG MT16  4,0X20,0MM, RES: ILM 4020N;  IMPLANT EPIKUT PLUS MT16  4,0X8,5MM, RES: ILM 4085N;  IMPLANT EPIKUT PLUS MT16  4,5X13,0MM, REF: ILM 4513N;  IMPLANT EPIKUT PLUS MT16  4,5X15,0MM, REF: ILM 4515N;  IMPLANT EPIKUT PLUS MT16  4,5X8,5MM, REF: ILM 4585N;  IMPLANT EPIKUT PLUS MT16  5,0X10,0MM, REF: ILM 5010N;  IMPLANT EPIKUT PLUS MT16  5,0X11,5MM, REF: ILM 5011N;  IMPLANT EPIKUT PLUS MT16  4,5X10,0MM, REF: ILM 4510N;  IMPLANT EPIKUT PLUS MT16  5,0X13,0MM, RES: ILM 5013N;  IMPLANT EPIKUT PLUS MT16  5,0X15,0MM, REF: ILM 5015N;  IMPLANT EPIKUT PLUS MT16  5,0X8,5MM, REF: ILM 5085N;  IMP EPIKUT PLUS LONG MT16  4,0X18,0MM, REF: ILM 4018N;  IMP EPIKUT PLUS LONG MT16  3,8X18,0MM, REF: ILM 3818N;  IMPLANT EPIKUT PLUS MT16  4,5X11,5MM, REF: ILM 4511N;  IMPLANT EPIKUT MT16  4,5X15,0MM, REF: ILM 4515;  IMPLANT EPIKUT MT16  4,5X8,5MM, REF: ILM 4585;  IMPLANT EPIKUT MT16  3,8X13,0MM, REF: ILM 3813;  IMPLANT EPIKUT MT16  3,8X15,0MM, REF: ILM 3815;  IMPLANT EPIKUT MT16  5,0X8,5MM, REF: ILM 5085;  IMPLANT EPIKUT MT16  3,8X11,5MM, REF: ILM 3811;  IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N;  IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N;  IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N",
  "description": "FDA recall Z-0017-2026 — S.I.N. Implant System Ltda is recalling IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N;  IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N;  IMPLANT EPIKUT PLUS MT16  3,5X13,0MM, REF: ILM 3513N;  IMPLANT EPIKUT PLUS MT16  3,5X15,0MM, REF: ILM 3515N;  IMPLANT EPIKUT PLUS MT16  3,8X10,0MM, REF: ILM 3810N;  IMPLANT CM16  3,8 X 11MM, REF: ILM 3811N;  IMPLANT EPIKUT PLUS MT16  3,8X15,0MM, REF: ILM 3815N;  IMPLANT EPIKUT PLUS MT16  4,0X10,0MM, REF: ILM 4010N;  IMPLANT EPIKUT PLUS MT16  4,0X11,5MM, REF: ILM 4011N;  IMPLANT EPIKUT PLUS MT16  4,0X13,0MM, REF: ILM 4013N;  IMP EPIKUT PLUS LONG MT16  4,0X20,0MM, RES: ILM 4020N;  IMPLANT EPIKUT PLUS MT16  4,0X8,5MM, RES: ILM 4085N;  IMPLANT EPIKUT PLUS MT16  4,5X13,0MM, REF: ILM 4513N;  IMPLANT EPIKUT PLUS MT16  4,5X15,0MM, REF: ILM 4515N;  IMPLANT EPIKUT PLUS MT16  4,5X8,5MM, REF: ILM 4585N;  IMPLANT EPIKUT PLUS MT16  5,0X10,0MM, REF: ILM 5010N;  IMPLANT EPIKUT PLUS MT16  5,0X11,5MM, REF: ILM 5011N;  IMPLANT EPIKUT PLUS MT16  4,5X10,0MM, REF: ILM 4510N;  IMPLANT EPIKUT PLUS MT16  5,0X13,0MM, RES: ILM 5013N;  IMPLANT EPIKUT PLUS MT16  5,0X15,0MM, REF: ILM 5015N;  IMPLANT EPIKUT PLUS MT16  5,0X8,5MM, REF: ILM 5085N;  IMP EPIKUT PLUS LONG MT16  4,0X18,0MM, REF: ILM 4018N;  IMP EPIKUT PLUS LONG MT16  3,8X18,0MM, REF: ILM 3818N;  IMPLANT EPIKUT PLUS MT16  4,5X11,5MM, REF: ILM 4511N;  IMPLANT EPIKUT MT16  4,5X15,0MM, REF: ILM 4515;  IMPLANT EPIKUT MT16  4,5X8,5MM, REF: ILM 4585;  IMPLANT EPIKUT MT16  3,8X13,0MM, REF: ILM 3813;  IMPLANT EPIKUT MT16  3,8X15,0MM, REF: ILM 3815;  IMPLANT EPIKUT MT16  5,0X8,5MM, REF: ILM 5085;  IMPLANT EPIKUT MT16  3,8X11,5MM, REF: ILM 3811;  IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N;  IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N;  IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N (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-0017-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N;  IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N;  IMPLANT EPIKUT PLUS MT16  3,5X13,0MM, REF: ILM 3513N;  IMPLANT EPIKUT PLUS MT16  3,5X15,0MM, REF: ILM 3515N;  IMPLANT EPIKUT PLUS MT16  3,8X10,0MM, REF: ILM 3810N;  IMPLANT CM16  3,8 X 11MM, REF: ILM 3811N;  IMPLANT EPIKUT PLUS MT16  3,8X15,0MM, REF: ILM 3815N;  IMPLANT EPIKUT PLUS MT16  4,0X10,0MM, REF: ILM 4010N;  IMPLANT EPIKUT PLUS MT16  4,0X11,5MM, REF: ILM 4011N;  IMPLANT EPIKUT PLUS MT16  4,0X13,0MM, REF: ILM 4013N;  IMP EPIKUT PLUS LONG MT16  4,0X20,0MM, RES: ILM 4020N;  IMPLANT EPIKUT PLUS MT16  4,0X8,5MM, RES: ILM 4085N;  IMPLANT EPIKUT PLUS MT16  4,5X13,0MM, REF: ILM 4513N;  IMPLANT EPIKUT PLUS MT16  4,5X15,0MM, REF: ILM 4515N;  IMPLANT EPIKUT PLUS MT16  4,5X8,5MM, REF: ILM 4585N;  IMPLANT EPIKUT PLUS MT16  5,0X10,0MM, REF: ILM 5010N;  IMPLANT EPIKUT PLUS MT16  5,0X11,5MM, REF: ILM 5011N;  IMPLANT EPIKUT PLUS MT16  4,5X10,0MM, REF: ILM 4510N;  IMPLANT EPIKUT PLUS MT16  5,0X13,0MM, RES: ILM 5013N;  IMPLANT EPIKUT PLUS MT16  5,0X15,0MM, REF: ILM 5015N;  IMPLANT EPIKUT PLUS MT16  5,0X8,5MM, REF: ILM 5085N;  IMP EPIKUT PLUS LONG MT16  4,0X18,0MM, REF: ILM 4018N;  IMP EPIKUT PLUS LONG MT16  3,8X18,0MM, REF: ILM 3818N;  IMPLANT EPIKUT PLUS MT16  4,5X11,5MM, REF: ILM 4511N;  IMPLANT EPIKUT MT16  4,5X15,0MM, REF: ILM 4515;  IMPLANT EPIKUT MT16  4,5X8,5MM, REF: ILM 4585;  IMPLANT EPIKUT MT16  3,8X13,0MM, REF: ILM 3813;  IMPLANT EPIKUT MT16  3,8X15,0MM, REF: ILM 3815;  IMPLANT EPIKUT MT16  5,0X8,5MM, REF: ILM 5085;  IMPLANT EPIKUT MT16  3,8X11,5MM, REF: ILM 3811;  IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N;  IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N;  IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "S.I.N. Implant System Ltda"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0017-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0017-2026: S.I.N. Implant System Ltda is recalling IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N;  IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N;  IMPLANT EPIKUT PLUS MT16  3,5X13,0MM, REF: ILM 3513N;  IMPLANT EPIKUT PLUS MT16  3,5X15,0MM, REF: ILM 3515N;  IMPLANT EPIKUT PLUS MT16  3,8X10,0MM, REF: ILM 3810N;  IMPLANT CM16  3,8 X 11MM, REF: ILM 3811N;  IMPLANT EPIKUT PLUS MT16  3,8X15,0MM, REF: ILM 3815N;  IMPLANT EPIKUT PLUS MT16  4,0X10,0MM, REF: ILM 4010N;  IMPLANT EPIKUT PLUS MT16  4,0X11,5MM, REF: ILM 4011N;  IMPLANT EPIKUT PLUS MT16  4,0X13,0MM, REF: ILM 4013N;  IMP EPIKUT PLUS LONG MT16  4,0X20,0MM, RES: ILM 4020N;  IMPLANT EPIKUT PLUS MT16  4,0X8,5MM, RES: ILM 4085N;  IMPLANT EPIKUT PLUS MT16  4,5X13,0MM, REF: ILM 4513N;  IMPLANT EPIKUT PLUS MT16  4,5X15,0MM, REF: ILM 4515N;  IMPLANT EPIKUT PLUS MT16  4,5X8,5MM, REF: ILM 4585N;  IMPLANT EPIKUT PLUS MT16  5,0X10,0MM, REF: ILM 5010N;  IMPLANT EPIKUT PLUS MT16  5,0X11,5MM, REF: ILM 5011N;  IMPLANT EPIKUT PLUS MT16  4,5X10,0MM, REF: ILM 4510N;  IMPLANT EPIKUT PLUS MT16  5,0X13,0MM, RES: ILM 5013N;  IMPLANT EPIKUT PLUS MT16  5,0X15,0MM, REF: ILM 5015N;  IMPLANT EPIKUT PLUS MT16  5,0X8,5MM, REF: ILM 5085N;  IMP EPIKUT PLUS LONG MT16  4,0X18,0MM, REF: ILM 4018N;  IMP EPIKUT PLUS LONG MT16  3,8X18,0MM, REF: ILM 3818N;  IMPLANT EPIKUT PLUS MT16  4,5X11,5MM, REF: ILM 4511N;  IMPLANT EPIKUT MT16  4,5X15,0MM, REF: ILM 4515;  IMPLANT EPIKUT MT16  4,5X8,5MM, REF: ILM 4585;  IMPLANT EPIKUT MT16  3,8X13,0MM, REF: ILM 3813;  IMPLANT EPIKUT MT16  3,8X15,0MM, REF: ILM 3815;  IMPLANT EPIKUT MT16  5,0X8,5MM, REF: ILM 5085;  IMPLANT EPIKUT MT16  3,8X11,5MM, REF: ILM 3811;  IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N;  IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N;  IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N",
      "text": "The FDA logged enforcement record Z-0017-2026: S.I.N. Implant System Ltda is voluntarily recalling IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N;  IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N;  IMPLANT EPIKUT PLUS MT16  3,5X13,0MM, REF: ILM 3513N;  IMPLANT EPIKUT PLUS MT16  3,5X15,0MM, REF: ILM 3515N;  IMPLANT EPIKUT PLUS MT16  3,8X10,0MM, REF: ILM 3810N;  IMPLANT CM16  3,8 X 11MM, REF: ILM 3811N;  IMPLANT EPIKUT PLUS MT16  3,8X15,0MM, REF: ILM 3815N;  IMPLANT EPIKUT PLUS MT16  4,0X10,0MM, REF: ILM 4010N;  IMPLANT EPIKUT PLUS MT16  4,0X11,5MM, REF: ILM 4011N;  IMPLANT EPIKUT PLUS MT16  4,0X13,0MM, REF: ILM 4013N;  IMP EPIKUT PLUS LONG MT16  4,0X20,0MM, RES: ILM 4020N;  IMPLANT EPIKUT PLUS MT16  4,0X8,5MM, RES: ILM 4085N;  IMPLANT EPIKUT PLUS MT16  4,5X13,0MM, REF: ILM 4513N;  IMPLANT EPIKUT PLUS MT16  4,5X15,0MM, REF: ILM 4515N;  IMPLANT EPIKUT PLUS MT16  4,5X8,5MM, REF: ILM 4585N;  IMPLANT EPIKUT PLUS MT16  5,0X10,0MM, REF: ILM 5010N;  IMPLANT EPIKUT PLUS MT16  5,0X11,5MM, REF: ILM 5011N;  IMPLANT EPIKUT PLUS MT16  4,5X10,0MM, REF: ILM 4510N;  IMPLANT EPIKUT PLUS MT16  5,0X13,0MM, RES: ILM 5013N;  IMPLANT EPIKUT PLUS MT16  5,0X15,0MM, REF: ILM 5015N;  IMPLANT EPIKUT PLUS MT16  5,0X8,5MM, REF: ILM 5085N;  IMP EPIKUT PLUS LONG MT16  4,0X18,0MM, REF: ILM 4018N;  IMP EPIKUT PLUS LONG MT16  3,8X18,0MM, REF: ILM 3818N;  IMPLANT EPIKUT PLUS MT16  4,5X11,5MM, REF: ILM 4511N;  IMPLANT EPIKUT MT16  4,5X15,0MM, REF: ILM 4515;  IMPLANT EPIKUT MT16  4,5X8,5MM, REF: ILM 4585;  IMPLANT EPIKUT MT16  3,8X13,0MM, REF: ILM 3813;  IMPLANT EPIKUT MT16  3,8X15,0MM, REF: ILM 3815;  IMPLANT EPIKUT MT16  5,0X8,5MM, REF: ILM 5085;  IMPLANT EPIKUT MT16  3,8X11,5MM, REF: ILM 3811;  IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N;  IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N;  IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N — reason: Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-07-30. Affected lots/codes: REF/UDI-DI/Lot(Expiration): ILM 3510N/7899995277558/X010469795(9/12/2026);  ILM 3511N/7899995274342/X020477141(7/11/2027), X040490928(1/3/2028), X030483330(1/2/2028), X030482747(9/2/2027), X030482813(10/10/2027), W100457486(2/9/2027), X030482750(9/2/2027), W020415041(10/12/2026), X020477137(3/4/2027);  ILM 3513N/7899995274335/W080447571(2/4/2028), X010469706(3/4/2028), X010471894(4/11/2028), W020415045(1/3/2028), X120531584(6/5/2028), X040490953(5/11/2028), Y010537386(6/12/2028);  ILM 3515N/7899995280893/W020420816(6/12/2028), X030484303(10/2/2028), X010472646(9/12/2028), X010472644(8/10/2028), X120531182(10/5/2028);  ILM 3810N/7899995274274/X120531775(10/5/2028);  ILM 3811N/7899995274229/X010471364(10/12/2028), X080513064(12/2/2028), X100521415(12/2/2028), X120531368(2/2/2029), X070504152(11/5/2028), X020478981(10/12/2028), X120531376(3/2/2029), X020478983(11/2/202), X010471356(10/12/2028), X100523193(1/2/2029);  ILM 3815N/7899995274168/X120531820(11/2/2029), X120531267(11/2/2029), X010473617(11/2/2029), V110406564(10/2/2029);  ILM 4010N/7899995274137/Y020538716(14/12/2028), X120530744(14/12/2028), X120530266(14/01/2029);  ILM 4011N/7899995274113/W100458406(15/12/2028), V110406330(15/12/2028), X120531292(16/05/2028), V110404633(15/12/2028), X090516009(16/01/2029);  ILM 4013N/7899995274106/W080449448(16/08/2027), X120531842(17/12/2028), X120530728(17/12/2028), X120530726(17/01/2029), X120530724(16/12/2028), X120530730(17/12/2028), Y010537900(17/12/2028), W090454924(16/09/2028), X010473946(16/12/2028), W100458876(16/09/2028), X120531618(17/12/2028), X090517847(16/12/2028), X120530300(16/12/2028), X120531930(17/12/2028), X010472967(16/12/2028), X090517840(16/12/2028), X090515626(16/12/2028), X090515638(16/12/2028);  ILM 4020N/7899995273499/X120530786(17/12/2028);  ILM 4085N/7899995274144/X120531822(18/06/2028);  ILM 4513N/7899995274038/X120530720(20/03/2028), Y010538078(22/09/2028), X120530722(20/10/2027), X120530849(22/06/2028);  ILM 4515N/7899995274021/X120530902(23/10/2028), X120530716(23/07/2028), X120530340(23/03/2028);  ILM 4585N/7899995274076/X110529195(25/11/2028), X110529193(25/10/2027);  ILM 5010N/7899995273970/X040490644(26/12/2028), X040490886(26/12/2028);  ILM 5011N/7899995273963/X120530851(26/12/2028);  ILM 4510N/7899995274069/Y010537208(18/12/2028);  ILM 5013N/7899995273956/X100522628(27/06/2027);  ILM 5015N/7899995273932/X120530844(28/12/2028), X040490872(27/12/2028);  ILM 5085N/7899995274007/X120530511(28/12/2028), X120530714(29/01/2029), X120530338(28/12/2028), Y010536031(30/05/2028);  ILM 4018N/7899995273529/Y010537853(17/12/2028);  ILM 3818N/7899995280886/Y010536867(13/12/2028);  ILM 4511N/7899995274045/X120531860(18/12/2028), X120531935(18/12/2028), X120530732(18/12/2028);  ILM 4515/7899995280169/X060497920(23/02/2028), X060497915(23/01/2028);  ILM 4585/7899995280251/X040490690(24/01/2028), X120529433(24/01/2029), X120529450(24/01/2029);  ILM 3813/7899995280527/Y020539359(6/2/2029);  ILM 3815/7899995280473/Y010535029(7/2/2029);  ILM 5085/7899995280091/X090516829(28/12/2028);  ILM 3811/7899995280534/X110528601(10/10/2028);  ILM 3820N/7899995273642/V110406210(13/12/2028), X020479077(X020479077);  ILM 4518N/7899995273437/W060438138(24/01/2028), X120531278(24/01/2028);  UCMC 6007N/7899995215895/Y010536358(30/10/2028);. 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-0017-2026&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-0017-2026&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-0017-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0017-2026 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-0017-2026&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-0017-2026&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-0017-2026/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-0017-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0017-2026",
            "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 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": "S.I.N. Implant System Ltda",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-07-30",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "REF/UDI-DI/Lot(Expiration): ILM 3510N/7899995277558/X010469795(9/12/2026);  ILM 3511N/7899995274342/X020477141(7/11/2027), X040490928(1/3/2028), X030483330(1/2/2028), X030482747(9/2/2027), X030482813(10/10/2027), W100457486(2/9/2027), X030482750(9/2/2027), W020415041(10/12/2026), X020477137(3/4/2027);  ILM 3513N/7899995274335/W080447571(2/4/2028), X010469706(3/4/2028), X010471894(4/11/2028), W020415045(1/3/2028), X120531584(6/5/2028), X040490953(5/11/2028), Y010537386(6/12/2028);  ILM 3515N/7899995280893/W020420816(6/12/2028), X030484303(10/2/2028), X010472646(9/12/2028), X010472644(8/10/2028), X120531182(10/5/2028);  ILM 3810N/7899995274274/X120531775(10/5/2028);  ILM 3811N/7899995274229/X010471364(10/12/2028), X080513064(12/2/2028), X100521415(12/2/2028), X120531368(2/2/2029), X070504152(11/5/2028), X020478981(10/12/2028), X120531376(3/2/2029), X020478983(11/2/202), X010471356(10/12/2028), X100523193(1/2/2029);  ILM 3815N/7899995274168/X120531820(11/2/2029), X120531267(11/2/2029), X010473617(11/2/2029), V110406564(10/2/2029);  ILM 4010N/7899995274137/Y020538716(14/12/2028), X120530744(14/12/2028), X120530266(14/01/2029);  ILM 4011N/7899995274113/W100458406(15/12/2028), V110406330(15/12/2028), X120531292(16/05/2028), V110404633(15/12/2028), X090516009(16/01/2029);  ILM 4013N/7899995274106/W080449448(16/08/2027), X120531842(17/12/2028), X120530728(17/12/2028), X120530726(17/01/2029), X120530724(16/12/2028), X120530730(17/12/2028), Y010537900(17/12/2028), W090454924(16/09/2028), X010473946(16/12/2028), W100458876(16/09/2028), X120531618(17/12/2028), X090517847(16/12/2028), X120530300(16/12/2028), X120531930(17/12/2028), X010472967(16/12/2028), X090517840(16/12/2028), X090515626(16/12/2028), X090515638(16/12/2028);  ILM 4020N/7899995273499/X120530786(17/12/2028);  ILM 4085N/7899995274144/X120531822(18/06/2028);  ILM 4513N/7899995274038/X120530720(20/03/2028), Y010538078(22/09/2028), X120530722(20/10/2027), X120530849(22/06/2028);  ILM 4515N/7899995274021/X120530902(23/10/2028), X120530716(23/07/2028), X120530340(23/03/2028);  ILM 4585N/7899995274076/X110529195(25/11/2028), X110529193(25/10/2027);  ILM 5010N/7899995273970/X040490644(26/12/2028), X040490886(26/12/2028);  ILM 5011N/7899995273963/X120530851(26/12/2028);  ILM 4510N/7899995274069/Y010537208(18/12/2028);  ILM 5013N/7899995273956/X100522628(27/06/2027);  ILM 5015N/7899995273932/X120530844(28/12/2028), X040490872(27/12/2028);  ILM 5085N/7899995274007/X120530511(28/12/2028), X120530714(29/01/2029), X120530338(28/12/2028), Y010536031(30/05/2028);  ILM 4018N/7899995273529/Y010537853(17/12/2028);  ILM 3818N/7899995280886/Y010536867(13/12/2028);  ILM 4511N/7899995274045/X120531860(18/12/2028), X120531935(18/12/2028), X120530732(18/12/2028);  ILM 4515/7899995280169/X060497920(23/02/2028), X060497915(23/01/2028);  ILM 4585/7899995280251/X040490690(24/01/2028), X120529433(24/01/2029), X120529450(24/01/2029);  ILM 3813/7899995280527/Y020539359(6/2/2029);  ILM 3815/7899995280473/Y010535029(7/2/2029);  ILM 5085/7899995280091/X090516829(28/12/2028);  ILM 3811/7899995280534/X110528601(10/10/2028);  ILM 3820N/7899995273642/V110406210(13/12/2028), X020479077(X020479077);  ILM 4518N/7899995273437/W060438138(24/01/2028), X120531278(24/01/2028);  UCMC 6007N/7899995215895/Y010536358(30/10/2028);",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution including in the states of TX, IL, KY, NC, TN, CO, CA, MO, MD, AL, FL, PA, UT, NE, ID, AZ, WA, OK, OR, NV, NJ, VA, NY, LA, CT, SD, SC, HI, KS, MA, MI, NM, OH, MT, WI, MN, ME.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}