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  "name": "ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-018-08",
  "description": "FDA recall Z-1728-2024 — Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-018-08 (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, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-018-08",
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      "name": "FDA recall Z-1728-2024: Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-018-08",
      "text": "The FDA logged enforcement record Z-1728-2024: Zimmer, Inc. is voluntarily recalling ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures  Item Number: 00-2357-018-08 — 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: 00889024055926 Lot Numbers: Lot Number 64370324 64370328 64370332 64370333 64370337 64370339 64370341 64370344 64370353 64370354 64370364 64370365 64370366 64370368 64370369 64370370 64406604 64406606 64406609 64406611 64406618 64406619 64406620 64406622 64406625 64406626 64452251 64452252 64452253 64464635 64464647 64464648 64464649 64464651 64464652 64464654 64464656 64464658 64464659 64464660 64464661 64464662 64464664 64464666 64464667 64475555 64475556 64488018 64488021 64488023 64488025 64488028 64488030 64488031 64488032 64488033 64488034 64488035 64488036 64488037 64488038 64538017 64544890 64544891 64544892 64544893 64544894 64544895 64609930 64609931 64609932 64629492 64629494 64629495 64629496 64629518 64629519 64629520 64629522 64629523 64629524 64629525 64629526 64629527 64714907 64714908 64714909 64714912 64714913 64714914 64800035 64800036 64800038 64800041 64800043 64800045 64800047 64800052 64800053 64800054 64800055 64800056 64800057 64800058 64800059 64800060 64800061 64800062 64800077 64800078 64800079 64800080 64800081 64800082 64896819 64896820 64896821 64896823 64896824 64896825 64896826 64896828 64896829 64896846 64896848 64896852 64896853 64896855 64896856 64896858 64896860 64910349 64910350 64910356 64910358 64917592 64917593 64917594 64917595 64917596 64917597 64917598 64917599 64917601 64917602 64917603 64917604 64938529 64938530 64938531 64938532 64938533 64938559 64938595 65021060 65021061 65021062 65021063 65021064 65021065 65021066 65021067 65021068 65021069 65069860 65069861 65069887 65069901 65069902 65241206 65241207 65241208 65305082 65305083 65305084 65305085 65305086 65305087 65305088 65322090 65322092 65328600 65328603 65383773 65383775 65383778 65383779 65383782 65499002 65499005 65521087 65934072 65934073 65977491 65990276. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1728-2024 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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            "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: 00889024055926 Lot Numbers: Lot Number 64370324 64370328 64370332 64370333 64370337 64370339 64370341 64370344 64370353 64370354 64370364 64370365 64370366 64370368 64370369 64370370 64406604 64406606 64406609 64406611 64406618 64406619 64406620 64406622 64406625 64406626 64452251 64452252 64452253 64464635 64464647 64464648 64464649 64464651 64464652 64464654 64464656 64464658 64464659 64464660 64464661 64464662 64464664 64464666 64464667 64475555 64475556 64488018 64488021 64488023 64488025 64488028 64488030 64488031 64488032 64488033 64488034 64488035 64488036 64488037 64488038 64538017 64544890 64544891 64544892 64544893 64544894 64544895 64609930 64609931 64609932 64629492 64629494 64629495 64629496 64629518 64629519 64629520 64629522 64629523 64629524 64629525 64629526 64629527 64714907 64714908 64714909 64714912 64714913 64714914 64800035 64800036 64800038 64800041 64800043 64800045 64800047 64800052 64800053 64800054 64800055 64800056 64800057 64800058 64800059 64800060 64800061 64800062 64800077 64800078 64800079 64800080 64800081 64800082 64896819 64896820 64896821 64896823 64896824 64896825 64896826 64896828 64896829 64896846 64896848 64896852 64896853 64896855 64896856 64896858 64896860 64910349 64910350 64910356 64910358 64917592 64917593 64917594 64917595 64917596 64917597 64917598 64917599 64917601 64917602 64917603 64917604 64938529 64938530 64938531 64938532 64938533 64938559 64938595 65021060 65021061 65021062 65021063 65021064 65021065 65021066 65021067 65021068 65021069 65069860 65069861 65069887 65069901 65069902 65241206 65241207 65241208 65305082 65305083 65305084 65305085 65305086 65305087 65305088 65322090 65322092 65328600 65328603 65383773 65383775 65383778 65383779 65383782 65499002 65499005 65521087 65934072 65934073 65977491 65990276",
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