ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal…
Medical device recall Z-1728-2024. Published in FDA’s Enforcement Report on May 8, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 8, 2024. Copied from openFDA on Oct 20, 2026.
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,799 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 20, 2024.
- FDA classified it on Apr 30, 2024.
- FDA’s Enforcement Report published it on May 8, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer, Inc., of Warsaw, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.