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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0618-2024.jsonld",
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  "name": "RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320    The RBL2320, Low Profile Primary Guide is an instrument used with a power system to  compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes to drill, and provide proper orientation for the installation of the screws.",
  "description": "FDA recall Z-0618-2024 — Acumed LLC is recalling RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320    The RBL2320, Low Profile Primary Guide is an instrument used with a power system to  compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes to drill, and provide proper orientation for the installation of the screws. (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "@type": "schema:MedicalDevice",
    "name": "RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320    The RBL2320, Low Profile Primary Guide is an instrument used with a power system to  compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes to drill, and provide proper orientation for the installation of the screws.",
    "manufacturer": {
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      "name": "Acumed LLC"
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  "claims": [
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0618-2024/enforcement-record",
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      "name": "FDA recall Z-0618-2024: Acumed LLC is recalling RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320    The RBL2320, Low Profile Primary Guide is an instrument used with a power system to  compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes to drill, and provide proper orientation for the installation of the screws.",
      "text": "The FDA logged enforcement record Z-0618-2024: Acumed LLC is voluntarily recalling RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320    The RBL2320, Low Profile Primary Guide is an instrument used with a power system to  compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes to drill, and provide proper orientation for the installation of the screws. — reason: Due to potential breakage during use.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-27. Affected lots/codes: Part Number: RBL2320 UDI Code / Batch-Lot Number 10806378118210-538351000000 / 538351 10806378118210-538352000000 / 538352 10806378118210-544036000000 / 544036 10806378118210-554505000000 / 554505 10806378118210-L1810012181031 / L1810012 10806378118210-L1902009190207 / L1902009 10806378118210-L1909017190918 / L1909017 10806378118210-L2001005200130 / L2001005 10806378118210-L2005002200504 / L2005002 10806378118210-L2010046000000 / L2010046 10806378118210-L2010048000000 / L2010048. A RECORDED FDA enforcement action (occurred=true).",
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        "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-0618-2024&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-0618-2024&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-0618-2024 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.",
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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-0618-2024/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.",
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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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      "name": "FDA recall details — Z-0618-2024",
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            "Field": "Classification",
            "Value": "Class II",
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Acumed LLC",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Due to potential breakage during use.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2023-11-27",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "Part Number: RBL2320 UDI Code / Batch-Lot Number 10806378118210-538351000000 / 538351 10806378118210-538352000000 / 538352 10806378118210-544036000000 / 544036 10806378118210-554505000000 / 554505 10806378118210-L1810012181031 / L1810012 10806378118210-L1902009190207 / L1902009 10806378118210-L1909017190918 / L1909017 10806378118210-L2001005200130 / L2001005 10806378118210-L2005002200504 / L2005002 10806378118210-L2010046000000 / L2010046 10806378118210-L2010048000000 / L2010048",
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            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NJ, OH, OR, SC, TX, UT, VA, WA, and WI. The country of Australia.",
            "Status": "recorded"
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