Use caution Medical device recall · FDA · Published May 22, 2024

Waldemar Link Endo Model SL Tibial Components Recall: Blind Screws Risk Prolonged Surgery

Waldemar Link recalls Endo Model SL Tibial Components with blind screws that cannot be loosened during surgery, potentially causing prolonged procedures. Affected units manufactured since June 1, 2022.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2411-2024Medical device Waldemar Link ›

Use caution until it’s fixed

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

Take action

Contact the company

Recalling firmWaldemar Link GmbH & Co. KG (Mfg Site)Oststr. 4-10 · Norderstedt, Germany

✎ GovInfoNow plain-language explainer

Waldemar Link is recalling specific tibial components used in joint surgery because their blind screws cannot be loosened during surgery. This could lead to longer surgeries and complications if the procedure needs adjustment. Patients using these components should contact the manufacturer for details. Read more at govinfonow.com/recall/55030-waldemar-link-endo-model-sl-tibial-components-recall-blind-screws.

Source Summary by GovInfoNow · govinfonow.com/recall/55030-waldemar-link-endo-model-sl-tibial-components-recall-blind-screws · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2411-2024

Cite this page

“Waldemar Link Endo Model SL Tibial Components Recall: Blind Screws Risk Prolonged Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55030-waldemar-link-endo-model-sl-tibial-components-recall-blind-screws. Based on FDA recall #Z-2411-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2411-2024%22&limit=1).

The FDA announced on May 22, 2024, that Waldemar Link is recalling Endo Model SL Tibial Components because blind screws cannot be loosened during surgery. The agency said the defect may prolong the operation due to changes in the cementing technique.

How to tell if you have it

Brand: Waldemar Link
Product: Endo Model SL Tibial Components
Model 16-2817/02, Small, W: 60mm (UDI-DI 04026575359202)
Model 16-2817/05, Medium, W: 65mm (UDI-DI 04026575359219)
Model 16-2817/07, Large, W: 75mm (UDI-DI 04026575359226)
Model 16-2817/32, Modular, Small, W: 60mm (UDI-DI 04026575370870)
Model 16-2817/35, Modular, Medium, W: 65mm (UDI-DI 04026575370887)
Model 16-2817/37, Modular, Large, W: 75mm (UDI-DI 04026575370894)
Lots manufactured since June 1, 2022
Sold nationwide in the U.S. and internationally

The hazard

According to the FDA, the blind screws of the modular tibial component cannot be loosened intraoperatively. This defect may prolong surgery due to an intraoperative change in procedure, likely related to the cementing technique.

Context

GovInfoNow's records show Waldemar Link has 21 other recalls on record since December 4, 2018. Other recent recalls of similar products include the Endo-Model Tibial Plateau Recall (July 6, 2026), the Embrace Drill Tower Wedged (25mm) Recall (Feb. 11, 2026), and the Endo-Model Plateau Recall (Jan. 12, 2026). Other recent recalls of similar products include the DURACON XL Angled Tibial Implants Recall (July 30, 2026), the HX-400U-30 Ligating Device Recall (Oct. 30, 2025), and the Total Knee System Femoral Valgus Adaptor Recall (May 20, 2026).

How to tell if you have this one

Check for the model numbers 16-2817/02, 16-2817/05, 16-2817/07, 16-2817/32, 16-2817/35, or 16-2817/37 on the product. These components were manufactured starting June 1, 2022.

Brand
Waldemar Link
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
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

Recall number	Product, codes & lots	Quantity
Z-2410-2024	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; 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.	552 units; 7351 units OUS
Z-2411-2024	Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm; Product UDI-DI 16-2817/02 04026575359202; 16-2817/05 04026575359219; 16-2817/07 04026575359226; 16-2817/32 04026575370870; 16-2817/35 04026575370887; 16-2817/37 04026575370894. All product lots manufactured since 01-Jun-2022.	114 units US; 2351 units OUS

Based on the official FDA remedy

What to do — step by step

Check Product Model
Look for the model numbers listed in the recall notice to confirm if your component is affected.
Contact Manufacturer
Reach out to Waldemar Link for specific instructions on how to handle the affected components.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

May 22, 2024Firm started the recall
Jul 18, 2024FDA classified it Class II
Jul 24, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/55030-waldemar-link-endo-model-sl-tibial-components-recall-blind-screws">Waldemar Link Endo Model SL Tibial Components Recall: Blind Screws Risk Prolonged Surgery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2411-2024 (May 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2411-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.