FDA Device recall Z-1728-2024
ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteoto…
- FDA Device
- Class II
- ongoing
- Published 2024-05-08
On 2024-05-08 the FDA classified a Class II recall of ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteoto… by Zimmer, citing 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 sin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1728-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-20 |
| Published | 2024-05-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Zimmer |
| Distribution | US |
Product
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
Identifiers
| code_info | GTIN: 00889024055926 Lot Numbers: Lot Number 64370324 64370328 64370332 64370333 64370337 64370339 64370341 64370344 64…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 6 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1728-2024%22
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