{
  "@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-1670-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers:    a)  REF 1-10003-100 (SIZE 1 Right Medial);   b)\tREF 1-10003-110 (SIZE 1 Left Medial);   c)\tREF 1-10003-200 (SIZE 2-Right Medial);   d)\tREF 1-10003-210 (SIZE 2-Left Medial);   e)\tREF 1-10003-300 (SIZE 3- Right Medial);   f)\tREF 1-10003-310 (SIZE 3- Left Medial);   g)\tREF 1-10003-400 (SIZE 4- Right Medial);   h)\tREF 1-10003-410 (SIZE 4- Left Medial);   i)\tREF 1-10003-500 (SIZE 5- Right Medial);   j)\tREF 1-10003-510 (SIZE 5- Left Medial);   k)\tREF 1-10003-600 (SIZE 6- Right Medial);   l)\tREF 1-10003-610 (SIZE 6- Left Medial);   m)\tREF 1-10003-700 (SIZE 7- Right Medial);   n)\tREF 1-10003-710 (SIZE 7- Left Medial);   o)  REF 1-10003-800, (SIZE 8 - Right Medial);   p)  REF 1-10003-810, (SIZE 8 - Left Medial);   Unicondylar knee prothesis",
  "description": "FDA recall Z-1670-2023 — Smith & Nephew, Inc. is recalling Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers:    a)  REF 1-10003-100 (SIZE 1 Right Medial);   b)\tREF 1-10003-110 (SIZE 1 Left Medial);   c)\tREF 1-10003-200 (SIZE 2-Right Medial);   d)\tREF 1-10003-210 (SIZE 2-Left Medial);   e)\tREF 1-10003-300 (SIZE 3- Right Medial);   f)\tREF 1-10003-310 (SIZE 3- Left Medial);   g)\tREF 1-10003-400 (SIZE 4- Right Medial);   h)\tREF 1-10003-410 (SIZE 4- Left Medial);   i)\tREF 1-10003-500 (SIZE 5- Right Medial);   j)\tREF 1-10003-510 (SIZE 5- Left Medial);   k)\tREF 1-10003-600 (SIZE 6- Right Medial);   l)\tREF 1-10003-610 (SIZE 6- Left Medial);   m)\tREF 1-10003-700 (SIZE 7- Right Medial);   n)\tREF 1-10003-710 (SIZE 7- Left Medial);   o)  REF 1-10003-800, (SIZE 8 - Right Medial);   p)  REF 1-10003-810, (SIZE 8 - Left Medial);   Unicondylar knee prothesis (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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1670-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers:    a)  REF 1-10003-100 (SIZE 1 Right Medial);   b)\tREF 1-10003-110 (SIZE 1 Left Medial);   c)\tREF 1-10003-200 (SIZE 2-Right Medial);   d)\tREF 1-10003-210 (SIZE 2-Left Medial);   e)\tREF 1-10003-300 (SIZE 3- Right Medial);   f)\tREF 1-10003-310 (SIZE 3- Left Medial);   g)\tREF 1-10003-400 (SIZE 4- Right Medial);   h)\tREF 1-10003-410 (SIZE 4- Left Medial);   i)\tREF 1-10003-500 (SIZE 5- Right Medial);   j)\tREF 1-10003-510 (SIZE 5- Left Medial);   k)\tREF 1-10003-600 (SIZE 6- Right Medial);   l)\tREF 1-10003-610 (SIZE 6- Left Medial);   m)\tREF 1-10003-700 (SIZE 7- Right Medial);   n)\tREF 1-10003-710 (SIZE 7- Left Medial);   o)  REF 1-10003-800, (SIZE 8 - Right Medial);   p)  REF 1-10003-810, (SIZE 8 - Left Medial);   Unicondylar knee prothesis",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Smith & Nephew, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1670-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1670-2023: Smith & Nephew, Inc. is recalling Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers:    a)  REF 1-10003-100 (SIZE 1 Right Medial);   b)\tREF 1-10003-110 (SIZE 1 Left Medial);   c)\tREF 1-10003-200 (SIZE 2-Right Medial);   d)\tREF 1-10003-210 (SIZE 2-Left Medial);   e)\tREF 1-10003-300 (SIZE 3- Right Medial);   f)\tREF 1-10003-310 (SIZE 3- Left Medial);   g)\tREF 1-10003-400 (SIZE 4- Right Medial);   h)\tREF 1-10003-410 (SIZE 4- Left Medial);   i)\tREF 1-10003-500 (SIZE 5- Right Medial);   j)\tREF 1-10003-510 (SIZE 5- Left Medial);   k)\tREF 1-10003-600 (SIZE 6- Right Medial);   l)\tREF 1-10003-610 (SIZE 6- Left Medial);   m)\tREF 1-10003-700 (SIZE 7- Right Medial);   n)\tREF 1-10003-710 (SIZE 7- Left Medial);   o)  REF 1-10003-800, (SIZE 8 - Right Medial);   p)  REF 1-10003-810, (SIZE 8 - Left Medial);   Unicondylar knee prothesis",
      "text": "The FDA logged enforcement record Z-1670-2023: Smith & Nephew, Inc. is voluntarily recalling Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers:    a)  REF 1-10003-100 (SIZE 1 Right Medial);   b)\tREF 1-10003-110 (SIZE 1 Left Medial);   c)\tREF 1-10003-200 (SIZE 2-Right Medial);   d)\tREF 1-10003-210 (SIZE 2-Left Medial);   e)\tREF 1-10003-300 (SIZE 3- Right Medial);   f)\tREF 1-10003-310 (SIZE 3- Left Medial);   g)\tREF 1-10003-400 (SIZE 4- Right Medial);   h)\tREF 1-10003-410 (SIZE 4- Left Medial);   i)\tREF 1-10003-500 (SIZE 5- Right Medial);   j)\tREF 1-10003-510 (SIZE 5- Left Medial);   k)\tREF 1-10003-600 (SIZE 6- Right Medial);   l)\tREF 1-10003-610 (SIZE 6- Left Medial);   m)\tREF 1-10003-700 (SIZE 7- Right Medial);   n)\tREF 1-10003-710 (SIZE 7- Left Medial);   o)  REF 1-10003-800, (SIZE 8 - Right Medial);   p)  REF 1-10003-810, (SIZE 8 - Left Medial);   Unicondylar knee prothesis — reason: Recent complaint data indicates that the revision rate may be trending higher than corresponding similar  devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-02. Affected lots/codes: a) REF 1-10003-100, UDI/DI 00885556872925;  b) REF 1-10003-110, UDI/DI 00885556872932; c) REF 1-10003-200, UDI/DI 00885556872949;  d) REF 1-10003-210, UDI/DI 00885556872956;  e) REF 1-10003-300, UDI/DI 00885556872963;  f) REF 1-10003-310, UDI/DI 00885556872970;  g) REF 1-10003-400, UDI/DI 00885556872987;  h) REF 1-10003-410, UDI/DI 00885556872994;  i) REF 1-10003-500, UDI/DI  00885556873007;  j) REF 1-10003-510, UDI/DI 00885556873014;  k) REF 1-10003-600, UDI/DI 00885556873021;  l) REF 1-10003-610, UDI/DI 00885556873038; m) REF 1-10003-700, UDI/DI 00885556873045;  n) REF 1-10003-710, UDI/DI 00885556873052;  o)  REF 1-10003-800, UDI/DI 00885556873069;  p)  REF 1-10003-810,  UDI/DI 00885556873076;    ALL BATCHES. 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-1670-2023&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-1670-2023&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-1670-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1670-2023 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-1670-2023&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-1670-2023&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-1670-2023/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-1670-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1670-2023",
            "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": "Smith & Nephew, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Recent complaint data indicates that the revision rate may be trending higher than corresponding similar  devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-02",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF 1-10003-100, UDI/DI 00885556872925;  b) REF 1-10003-110, UDI/DI 00885556872932; c) REF 1-10003-200, UDI/DI 00885556872949;  d) REF 1-10003-210, UDI/DI 00885556872956;  e) REF 1-10003-300, UDI/DI 00885556872963;  f) REF 1-10003-310, UDI/DI 00885556872970;  g) REF 1-10003-400, UDI/DI 00885556872987;  h) REF 1-10003-410, UDI/DI 00885556872994;  i) REF 1-10003-500, UDI/DI  00885556873007;  j) REF 1-10003-510, UDI/DI 00885556873014;  k) REF 1-10003-600, UDI/DI 00885556873021;  l) REF 1-10003-610, UDI/DI 00885556873038; m) REF 1-10003-700, UDI/DI 00885556873045;  n) REF 1-10003-710, UDI/DI 00885556873052;  o)  REF 1-10003-800, UDI/DI 00885556873069;  p)  REF 1-10003-810,  UDI/DI 00885556873076;    ALL BATCHES",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}