{ "@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-0101-2024.jsonld", "@type": "schema:Dataset", "name": "MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1", "description": "FDA recall Z-0101-2024 — Mazor Robotics Ltd is recalling MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1 (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-0101-2024&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1", "manufacturer": { "@type": "schema:Organization", "name": "Mazor Robotics Ltd" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0101-2024/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-0101-2024: Mazor Robotics Ltd is recalling MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1", "text": "The FDA logged enforcement record Z-0101-2024: Mazor Robotics Ltd is voluntarily recalling MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1 — reason: Software update. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-05. Affected lots/codes: GTIN 07290109180465, Serial Numbers: 4000770717, 4000800717, 4000810817, 4000820817, 4000830817, 4000840817, 4000850817, 4000870817, 4000880817, 4000890917, 4000900917, 4000910917, 4000920917, 4000930917, 4000940917, 4000951017, 4000961017, 4000971017, 4000981017, 4000991017, 4001001017, 4001011117, 4001041117, 4001061117, 4001071217, 4001081217, 4001091217, 4001101217, 4001111217, 4001121217, 4001130118, 4001140118, 4001150118, 4001160118, 4001180118, 400-26-112016, 400-27-112016, 400-29-122016, 400-30-122016, 400-31-122016, 400-36-122016, 400-38-122016, 400-44-022017, 400-47-022017, 400-48-022017, 400-50-032017, 400-51-032017, 400-53-032017, 400-54-032017, 400-55-032017, 400-56-032017, 400-59-052017, 400-60-052017, 400-61-062017, 400-63-062017, 400-64-062017, 400-65-062017, 400-67-062017, 400-68-062017, 400-69-062017, 400-71-062017, 400-72-062017, 400-73-062017, 400-75-062017, 400-78-072017, 400-79-072017; GTIN 07290109181158, Serial Numbers: 4001200218, 4001210218, 4001270318, 4001280318, 4001300518, 4001310518, 4001320518, 4001330618, 4001360618, 4001370718, 4001390818, 4001400818, 4001410918, 4001430918, 4001440918, 4001450918, 4001470918, 4001481018, 4001501018, 4001511018, 4001521118, 4001531118, 4001541118, 4001551118, 4001561118, 4001571118, 4001601218, 4001611218, 4001631218, 4001641218, 4001651218, 4001680119, 4001690119, 4001710119, 4001740219; GTIN 07290109183213, Serial Numbers: 4001770219, 4001780219, 4001790219, 4001800219, 4001820219, 4001840219, 4001850219, 4001900319, 4001920419, 4001940419, 4001960419, 4001970419, 4001980419, 4001990419, 4002000419, 4002010419, 4002020419, 4002060519, 4002070519, 4002080519, 4002090519, 4002100519, 4002140619, 4002150619, 4002160619, 4002170619, 4002180619, 4002220719, 4002230819, 4002240819, 4002250819, 4002260819, 4002270819, 4002280819, 4002290819, 4002300819, 4002310919, 4002330919, 4002340919, 4002350919, 4002360919, 4002370919, 4002380919, 4002390919, 4002400919, 4002411019, 4002421019, 4002441019, 4002451019, 4002461019, 4002511119, 4002531119, 4002541119, 4002551119, 4002561119, 4002591119, 4002611219, 4002621219, 4002631219, 4002641219, 4002661219, 4002681219, 4002720120, 4002730120, 4002740120, 4002750120, 4002790120, 4002810120, 4002820120, 4002830220, 4002850220, 4002880220, 4002900220, 4002950220, 4002960220, 4002990220, 4003000320, 4003020320, 4003030320, 4003040320, 4003050320, 4003060320, 4003080320, 4003100320, 4003120320, 4003130320, 4003150320, 4003160320, 4003170320, 4003180320, 4003190320, 4003200320, 4003250520, 4003260520, 4003270520, 4003290520, 4003300620, 4003310520, 4003330620, 4003340620, 4003350620, 4003360620, 4003390820, 4003410920, 4003420920, 4003430920, 4003440920, 4003450920, 4003460920, 4003471120, 4003481120, 4003491120, 4003501120, 4003541120, 4003550121, 4003560121, 4003640221, 4003680421, 4003700521, 4003710621, 4003720521, 4003730621, 4003740621, 4003760621, 4003780621, 4003800821, 4003810821, 4003820821, 4003840821, 4003850821, 4003860821, 4003870821, 4003880821, 4003930921, 4003940921, 4003950921, 4003960921, 4003970921, 4003981021, 4003991021, 4004001021, 4004011021, 4004021021, 4004031021, 4004041021, 4004061121, 4004081121, 4004101121, 4004131121, 4004141121, 4004151121, 4004181221, 4004231221, 4004241221, 4004270122, 4004290122, 4004300122, 4004310122, 4004320122, 4004330122, 4004340122, 4004350122, 4004370122, 4004380122, 4004410222, 4004500322, 4004520322, 4004540322, 4004550322, 4004560322, 4004600322, 4004610322, 4004620322, 4004630322, 4004650322, 4004660322, 4004670322, 4002050419R, 4002860220R; GTIN 07290115751376, Serial Numbers: 4004680322, 4004700322, 4004710522, 4004790522, 4004810522, 4004830522, 4004870522, 4004910622, 4004950622, 4005030722, 4005080722, 4005130822, 4005140822, 4005150822, 4005200822, 4005210922, 4005220922, 4005230922, 4005240922, 4005250922, 4005290922, 4005330922, 4005340922, 4005350922, 4005360922, 4005401122, 4005431122, 4005451122, 4005471122, 4005481122, 4005501122, 4005521222, 4005551222, 4005561222, 4005571222, 4005621222, (new 04/11/2024): 4004251221, 4004440222, 4004930622, 4004980622, 4005491122, 4005960223, 4006070223, 4006750823. 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-0101-2024&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-0101-2024&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-0101-2024/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-0101-2024 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-0101-2024&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-0101-2024&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-0101-2024/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-0101-2024", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-0101-2024", "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": "Mazor Robotics Ltd", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "Software update", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2023-09-05", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "GTIN 07290109180465, Serial Numbers: 4000770717, 4000800717, 4000810817, 4000820817, 4000830817, 4000840817, 4000850817, 4000870817, 4000880817, 4000890917, 4000900917, 4000910917, 4000920917, 4000930917, 4000940917, 4000951017, 4000961017, 4000971017, 4000981017, 4000991017, 4001001017, 4001011117, 4001041117, 4001061117, 4001071217, 4001081217, 4001091217, 4001101217, 4001111217, 4001121217, 4001130118, 4001140118, 4001150118, 4001160118, 4001180118, 400-26-112016, 400-27-112016, 400-29-122016, 400-30-122016, 400-31-122016, 400-36-122016, 400-38-122016, 400-44-022017, 400-47-022017, 400-48-022017, 400-50-032017, 400-51-032017, 400-53-032017, 400-54-032017, 400-55-032017, 400-56-032017, 400-59-052017, 400-60-052017, 400-61-062017, 400-63-062017, 400-64-062017, 400-65-062017, 400-67-062017, 400-68-062017, 400-69-062017, 400-71-062017, 400-72-062017, 400-73-062017, 400-75-062017, 400-78-072017, 400-79-072017; GTIN 07290109181158, Serial Numbers: 4001200218, 4001210218, 4001270318, 4001280318, 4001300518, 4001310518, 4001320518, 4001330618, 4001360618, 4001370718, 4001390818, 4001400818, 4001410918, 4001430918, 4001440918, 4001450918, 4001470918, 4001481018, 4001501018, 4001511018, 4001521118, 4001531118, 4001541118, 4001551118, 4001561118, 4001571118, 4001601218, 4001611218, 4001631218, 4001641218, 4001651218, 4001680119, 4001690119, 4001710119, 4001740219; GTIN 07290109183213, Serial Numbers: 4001770219, 4001780219, 4001790219, 4001800219, 4001820219, 4001840219, 4001850219, 4001900319, 4001920419, 4001940419, 4001960419, 4001970419, 4001980419, 4001990419, 4002000419, 4002010419, 4002020419, 4002060519, 4002070519, 4002080519, 4002090519, 4002100519, 4002140619, 4002150619, 4002160619, 4002170619, 4002180619, 4002220719, 4002230819, 4002240819, 4002250819, 4002260819, 4002270819, 4002280819, 4002290819, 4002300819, 4002310919, 4002330919, 4002340919, 4002350919, 4002360919, 4002370919, 4002380919, 4002390919, 4002400919, 4002411019, 4002421019, 4002441019, 4002451019, 4002461019, 4002511119, 4002531119, 4002541119, 4002551119, 4002561119, 4002591119, 4002611219, 4002621219, 4002631219, 4002641219, 4002661219, 4002681219, 4002720120, 4002730120, 4002740120, 4002750120, 4002790120, 4002810120, 4002820120, 4002830220, 4002850220, 4002880220, 4002900220, 4002950220, 4002960220, 4002990220, 4003000320, 4003020320, 4003030320, 4003040320, 4003050320, 4003060320, 4003080320, 4003100320, 4003120320, 4003130320, 4003150320, 4003160320, 4003170320, 4003180320, 4003190320, 4003200320, 4003250520, 4003260520, 4003270520, 4003290520, 4003300620, 4003310520, 4003330620, 4003340620, 4003350620, 4003360620, 4003390820, 4003410920, 4003420920, 4003430920, 4003440920, 4003450920, 4003460920, 4003471120, 4003481120, 4003491120, 4003501120, 4003541120, 4003550121, 4003560121, 4003640221, 4003680421, 4003700521, 4003710621, 4003720521, 4003730621, 4003740621, 4003760621, 4003780621, 4003800821, 4003810821, 4003820821, 4003840821, 4003850821, 4003860821, 4003870821, 4003880821, 4003930921, 4003940921, 4003950921, 4003960921, 4003970921, 4003981021, 4003991021, 4004001021, 4004011021, 4004021021, 4004031021, 4004041021, 4004061121, 4004081121, 4004101121, 4004131121, 4004141121, 4004151121, 4004181221, 4004231221, 4004241221, 4004270122, 4004290122, 4004300122, 4004310122, 4004320122, 4004330122, 4004340122, 4004350122, 4004370122, 4004380122, 4004410222, 4004500322, 4004520322, 4004540322, 4004550322, 4004560322, 4004600322, 4004610322, 4004620322, 4004630322, 4004650322, 4004660322, 4004670322, 4002050419R, 4002860220R; GTIN 07290115751376, Serial Numbers: 4004680322, 4004700322, 4004710522, 4004790522, 4004810522, 4004830522, 4004870522, 4004910622, 4004950622, 4005030722, 4005080722, 4005130822, 4005140822, 4005150822, 4005200822, 4005210922, 4005220922, 4005230922, 4005240922, 4005250922, 4005290922, 4005330922, 4005340922, 4005350922, 4005360922, 4005401122, 4005431122, 4005451122, 4005471122, 4005481122, 4005501122, 4005521222, 4005551222, 4005561222, 4005571222, 4005621222, (new 04/11/2024): 4004251221, 4004440222, 4004930622, 4004980622, 4005491122, 4005960223, 4006070223, 4006750823", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "US Nationwide distribution.", "Status": "recorded" } } ] } ] }