ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal…
Medical device recall Z-1727-2024. 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, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-06
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: 00889024055919 Lot Numbers: 64403506 64403507 64403508 64403509 64403510 64403511 64403512 64403513 64403514 64403515 64403516 64403517 64403518 64403519 64403520 64403521 64403522 64403523 64403524 64403525 64403526 64423743…
Every code shown here, 1,996 characters
GTIN: 00889024055919 Lot Numbers: 64403506 64403507 64403508 64403509 64403510 64403511 64403512 64403513 64403514 64403515 64403516 64403517 64403518 64403519 64403520 64403521 64403522 64403523 64403524 64403525 64403526 64423743 64423744 64423745 64496313 64496314 64496315 64496316 64496317 64496318 64496319 64496320 64497330 64497331 64497332 64497333 64497334 64497335 64497336 64497337 64497338 64497411 64497412 64497413 64497414 64497423 64497436 64497439 64497446 64497448 64497449 64497450 64497454 64497455 64497458 64497460 64497461 64497462 64538004 64538005 64538006 64538007 64538008 64538009 64538010 64538011 64538012 64538013 64538014 64538015 64538016 64563586 64563589 64563590 64563592 64563611 64563617 64580493 64580494 64580495 64580496 64580498 64580501 64580503 64581249 64581250 64581251 64581252 64581253 64581254 64581255 64599906 64599907 64599908 64599909 64599910 64599911 64599912 64599913 64599914 64599915 64599916 64599917 64599918 64599925 64599926 64599927 64599957 64599958 64599959 64599960 64599961 64599962 64599963 64629444 64629445 64629446 64629447 64629449 64629450 64629468 64629469 64629470 64629473 64629475 64629476 64629477 64629484 64629485 64629486 64629488 64629489 64629490 64629491 64660068 64660069 64660070 64676547 64676549 64676552 64676555 64676564 64676592 64676593 64676596 64676597 64676599 64676601 64676602 64677064 64677065 64700626 64700639 64700640 64700641 64700649 64700666 64700668 64700670 64700673 64700675 64700678 64700679 64700681 64732261 64732262 64732263 64732264 64732265 64739593 64739594 64739595 64739605 64739606 64739607 64739608 64739609 64739610 64739611 64739612 64739613 64739614 64826552 64826555 64826556 64826557 64826558 64826559 64826560 64844778 64844779 64844780 64844781 64863953 64863955 64863957 64863960 64863962 64863964 64863966 64863968 64863969 64863972 64863978 64863980 64896861 64896866 64896882 64896883 64896884 64896885 64910581 64910583 64910586 64910588 64917619 64917620 64917621…
FDA’s list runs to 3,642 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 3,642 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.