ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal…
Medical device recall Z-1726-2024. 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, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-04
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI Number: 00889024055902 Lot Numbers: Lot Number 64362992 64362993 64362994 64362995 64362996 64362997 64362998 64362999 64363001 64363002 64363003 64363004 64363005 64363006 64363007 64363008 64363015 64363016 64363017 64363018 64452231…
Every code shown here, 1,995 characters
UDI Number: 00889024055902 Lot Numbers: Lot Number 64362992 64362993 64362994 64362995 64362996 64362997 64362998 64362999 64363001 64363002 64363003 64363004 64363005 64363006 64363007 64363008 64363015 64363016 64363017 64363018 64452231 64452232 64452233 64452234 64452235 64452236 64452237 64452238 64452239 64452240 64452241 64452242 64452243 64452244 64452245 64452246 64452247 64452248 64464613 64464614 64464616 64464618 64464620 64464623 64464625 64464626 64464628 64475451 64475452 64475453 64475454 64475455 64475456 64482183 64482197 64482283 64482341 64482380 64482393 64482402 64482404 64482442 64482484 64537925 64537926 64537927 64537928 64537929 64537936 64537937 64537938 64537939 64537940 64537941 64537942 64537943 64537944 64537945 64537946 64537947 64537948 64537949 64537950 64537951 64537952 64537953 64537954 64537955 64537956 64537957 64537958 64552295 64552296 64552297 64556990 64556991 64557407 64557408 64557411 64557412 64557413 64557414 64563337 64563339 64563341 64563342 64563497 64563523 64563531 64563544 64563546 64563548 64563553 64563554 64563555 64563556 64629033 64629034 64629035 64629036 64629037 64629428 64629429 64629432 64629438 64629440 64629441 64629442 64638181 64638183 64638184 64638185 64638187 64638188 64638189 64638193 64638195 64638373 64638374 64638375 64638377 64638379 64638383 64638440 64638441 64638442 64638443 64638444 64638445 64638446 64638447 64638448 64638449 64638450 64638455 64648164 64648165 64648166 64648167 64648168 64648169 64648173 64648174 64648176 64648177 64648178 64648179 64648180 64648181 64648182 64648186 64648187 64648190 64648191 64648194 64648196 64698164 64698172 64698179 64698183 64698191 64700574 64700575 64700576 64700611 64700612 64732237 64732238 64732239 64732240 64732241 64732251 64732252 64732253 64732254 64732255 64732256 64732257 64732258 64732259 64732260 64739431 64739432 64739433 64739591 64739592 64923371 64923372 64923374 64923376 64923378 64923379 64923381 64923383 64923386 64923388…
FDA’s list runs to 3,254 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 3,254 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.