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  "name": "ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-017-08",
  "description": "FDA recall Z-1724-2024 — Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-017-08 (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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    "name": "ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-017-08",
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      "name": "FDA recall Z-1724-2024: Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-017-08",
      "text": "The FDA logged enforcement record Z-1724-2024: Zimmer, Inc. is voluntarily recalling ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-017-08 — 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: 00889024055889 Lot Numbers: 64475412 64475418 64475422 64475426 64475427 64475428 64475431 64475435 64475439 64475443 64475444 64475445 64475446 64475447 64475448 64475449 64475450 64482031 64482032 64482033 64482034 64482035 64482042 64482043 64482044 64482045 64482046 64482047 64482048 64482051 64482052 64482057 64528508 64528509 64629014 64629015 64629017 64629018 64629019 64629020 64629022 64629023 64629024 64629025 64660057 64660060 64660063 64660066 64660067 64800086 64800087 64800088 64800089 64800090 64800091 64811207 64811208 64811209 64811210 64811212 64811213 64811214 64811215 65060838 65060839 65060840 65060841 65060842 65060843 65060844 65060845 65060846 65060847 65060848 65060849 65060850 65060851 65060852 65060853 65060854 65060855 65074872 65074873 65074874 65074875 65074876 65074877 65192591 65192592 65192593 65192594 65192595 65192596 65192597 65192598 65192599 65192601 65192602 65192603 65229326 65229327 65229328 65229332 65229337 65229341 65229344 65229348 65328548 65537763 65537767 65537771 66108602 66108605 66240694. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1724-2024 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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      "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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      "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": "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",
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            "Value": "GTIN: 00889024055889 Lot Numbers: 64475412 64475418 64475422 64475426 64475427 64475428 64475431 64475435 64475439 64475443 64475444 64475445 64475446 64475447 64475448 64475449 64475450 64482031 64482032 64482033 64482034 64482035 64482042 64482043 64482044 64482045 64482046 64482047 64482048 64482051 64482052 64482057 64528508 64528509 64629014 64629015 64629017 64629018 64629019 64629020 64629022 64629023 64629024 64629025 64660057 64660060 64660063 64660066 64660067 64800086 64800087 64800088 64800089 64800090 64800091 64811207 64811208 64811209 64811210 64811212 64811213 64811214 64811215 65060838 65060839 65060840 65060841 65060842 65060843 65060844 65060845 65060846 65060847 65060848 65060849 65060850 65060851 65060852 65060853 65060854 65060855 65074872 65074873 65074874 65074875 65074876 65074877 65192591 65192592 65192593 65192594 65192595 65192596 65192597 65192598 65192599 65192601 65192602 65192603 65229326 65229327 65229328 65229332 65229337 65229341 65229344 65229348 65328548 65537763 65537767 65537771 66108602 66108605 66240694",
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