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  "name": "AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118",
  "description": "FDA recall Z-2020-2023 — Tornier, Inc is recalling AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118",
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      "name": "Tornier, Inc"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2020-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2020-2023: Tornier, Inc is recalling AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118",
      "text": "The FDA logged enforcement record Z-2020-2023: Tornier, Inc is voluntarily recalling AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 — reason: A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-06-12. Affected lots/codes: GTIN 00846832069408, Serial Numbers:  AZ1322077001, AZ1322077002, AZ1322077003, AZ1322077004, AZ1322077005, AZ1322077006, AZ1322077007, AZ1322077008, AZ1322077009, AZ1322077010, AZ1322077011, AZ1322077012, AZ1322077013, AZ1322077014, AZ1322077015, AZ1322077016, AZ1322077017, AZ1322077018, AZ1322077019, AZ1322077020, AZ1322077021, AZ1322077022, AZ1322077023, AZ1322077024, AZ1322077025, AZ1322077026, AZ1322077027, AZ1322077028, AZ1322077029, AZ1322077030, AZ1322077031, AZ1322077032, AZ1322077033, AZ1322077034, AZ1322077035, AZ1322077036, AZ1322077037, AZ1322077038, AZ1322077039, AZ1322077040, AZ1322077041, AZ1322077042, AZ1322077043, AZ1322077044, AZ1322077045, AZ1322077046, AZ1322077047, AZ1322077048, AZ1322077049, AZ1322077050, AZ1322077051, AZ1322077052, AZ1322077053, AZ1322077054, AZ1322077055. A RECORDED FDA enforcement action (occurred=true).",
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        "supported": true,
        "adjudged": true,
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        "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-2020-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-2020-2023&lang=eng"
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      "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."
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      "name": "FDA classified recall Z-2020-2023 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.",
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      "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-2020-2023/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.",
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        "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."
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            "Status": "recorded"
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            "Field": "Reason",
            "Value": "A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.",
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            "Field": "Initiated",
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            "Value": "GTIN 00846832069408, Serial Numbers:  AZ1322077001, AZ1322077002, AZ1322077003, AZ1322077004, AZ1322077005, AZ1322077006, AZ1322077007, AZ1322077008, AZ1322077009, AZ1322077010, AZ1322077011, AZ1322077012, AZ1322077013, AZ1322077014, AZ1322077015, AZ1322077016, AZ1322077017, AZ1322077018, AZ1322077019, AZ1322077020, AZ1322077021, AZ1322077022, AZ1322077023, AZ1322077024, AZ1322077025, AZ1322077026, AZ1322077027, AZ1322077028, AZ1322077029, AZ1322077030, AZ1322077031, AZ1322077032, AZ1322077033, AZ1322077034, AZ1322077035, AZ1322077036, AZ1322077037, AZ1322077038, AZ1322077039, AZ1322077040, AZ1322077041, AZ1322077042, AZ1322077043, AZ1322077044, AZ1322077045, AZ1322077046, AZ1322077047, AZ1322077048, AZ1322077049, AZ1322077050, AZ1322077051, AZ1322077052, AZ1322077053, AZ1322077054, AZ1322077055",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.",
            "Status": "recorded"
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