Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02,…
Medical device recall Z-2410-2024. Published in FDA’s Enforcement Report on Jul 24, 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 Jul 24, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 552 units; 7351 units OUS how much, in FDA’s words
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?
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33
552 units; 7351 units OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product UDI-DI: 1 15-2814/01 04026575316243 2 15-2814/02 04026575316281 3 15-2814/03 04026575316298 4 15-2814/04 04026575316304 5 15-2815/11 04026575316007 6 15-2815/12 04026575316014 7 15-2816/11 04026575316021 8 15-2816/12 04026575316038…
Every code shown here, 1,331 characters
Product UDI-DI: 1 15-2814/01 04026575316243 2 15-2814/02 04026575316281 3 15-2814/03 04026575316298 4 15-2814/04 04026575316304 5 15-2815/11 04026575316007 6 15-2815/12 04026575316014 7 15-2816/11 04026575316021 8 15-2816/12 04026575316038 9 15-2817/11 04026575316052 10 15-2817/12 04026575316069 11 15-2818/11 04026575316076 12 15-2818/12 04026575316083 13 15-2834/01 04026575316731 14 15-2834/02 04026575316748 15 15-2834/03 04026575316755 16 15-2834/04 04026575316762 17 15-2835/11 04026575316557 18 15-2835/12 04026575316564 19 15-2836/11 04026575316571 20 15-2836/12 04026575316588 21 15-2837/11 04026575316595 22 15-2837/12 04026575316601 23 15-2838/11 04026575316618 24 15-2838/12 04026575316625 25 15-3815/11 04026575034727 26 15-3815/12 04026575034734 27 15-3816/11 04026575034741 28 15-3816/12 04026575034758 29 15-3817/11 04026575164042 30 15-3817/12 04026575164059 31 15-3818/11 04026575164028 32 15-3818/12 04026575164035 33 15-8521/05 04026575383207 34 15-8521/07 04026575383221 35 15-8521/09 04026575383238 36 15-8521/11 04026575383245 37 15-8521/13 04026575383269 38 15-8521/15 04026575383283 39 15-8521/25 04026575386406 40 15-8521/27 04026575386413 41 15-8521/29 04026575386420 42 15-8521/31 04026575386437 43 15-8521/33 04026575386444 44 15-8521/35 04026575386451 All Product lots manufactured since 01-Jun-2022.
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.
Nationwide Foreign: Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Israel Italy Kenya Lithuania Luxembourg Mexico Netherlands Norway Peru Poland Romania Saudi Arabia Slovakia Slovenia Spain Sweden Switzerland Thailand T¿rkiye Ukraine United Arab Emirates United Kingdom Uruguay Vietnam
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 May 22, 2024.
- FDA classified it on Jul 18, 2024.
- FDA’s Enforcement Report published it on Jul 24, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Waldemar Link GmbH & Co. KG (Mfg Site), of Norderstedt, Germany.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
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.