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  "name": "ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-017-10",
  "description": "FDA recall Z-1725-2024 — Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-017-10 (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": "ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-017-10",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1725-2024/enforcement-record",
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      "name": "FDA recall Z-1725-2024: Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-017-10",
      "text": "The FDA logged enforcement record Z-1725-2024: Zimmer, Inc. is voluntarily recalling ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-017-10 — reason: Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-20. Affected lots/codes: GTIN: 00889024055896 Lot Numbers: Lot Number 64528516 64528517 64528518 64528522 64528523 64528527 64528528 64528529 64528530 64629028 64629030 64629031 64677270 64677272 64677276 64677278 64677279 64677281 64817167 64817168 64817169 64817170 64817171 64817172 64817173 64817174 64817175 64817176 65021088 65021089 65021090 65021091 65021092 65021093 65092268 65092269 65092270 65092271 65092272 65092273 65092274 65092275 65092276 65092277 65092278 65092279 65192604 65192605 65192606 65192607 65192608 65192609 66174613 66187674 66194640 66194643 66194646 66194649 66194652 66209353 66209363 66240704. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1725-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
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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-1725-2024 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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      "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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1725-2024/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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        "adjudicator": null
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      "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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            "Field": "Recalling firm",
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            "Field": "Reason",
            "Value": "Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention",
            "Status": "recorded"
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            "Value": "GTIN: 00889024055896 Lot Numbers: Lot Number 64528516 64528517 64528518 64528522 64528523 64528527 64528528 64528529 64528530 64629028 64629030 64629031 64677270 64677272 64677276 64677278 64677279 64677281 64817167 64817168 64817169 64817170 64817171 64817172 64817173 64817174 64817175 64817176 65021088 65021089 65021090 65021091 65021092 65021093 65092268 65092269 65092270 65092271 65092272 65092273 65092274 65092275 65092276 65092277 65092278 65092279 65192604 65192605 65192606 65192607 65192608 65192609 66174613 66187674 66194640 66194643 66194646 66194649 66194652 66209353 66209363 66240704",
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            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.",
            "Status": "recorded"
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