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Use caution Medical device recall · FDA · Published May 24, 2022

Waldemar Link Tibial Component Modular Prosthesis Recall: Risk of Blind Screws Causing

Waldemar Link recalls specific orthopedic prosthesis models due to risk of blind screws that cannot be loosened during surgery, potentially prolonging procedures. Affected models include Small (W 16-2817/32), Medium (W 16-2817/35), and Large (W 16-2817/37).

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

🇺🇸 FDA recall #Z-1380-2022Medical deviceWaldemar Link ›
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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 orthopedic prosthesis models because blind screws in the tibial component may not loosen during surgery, leading to longer procedures. This recall affects surgeons and hospitals using the recalled models. Read more at govinfonow.com/recall/60664-waldemar-link-tibial-component-modular-prosthesis-recall-risk-of-blind.

Source Summary by GovInfoNow · govinfonow.com/recall/60664-waldemar-link-tibial-component-modular-prosthesis-recall-risk-of-blind · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1380-2022

Cite this page

“Waldemar Link Tibial Component Modular Prosthesis Recall: Risk of Blind Screws Causing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60664-waldemar-link-tibial-component-modular-prosthesis-recall-risk-of-blind. Based on FDA recall #Z-1380-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1380-2022%22&limit=1).

The FDA announced on May 24, 2022, that Waldemar Link GmbH & Co. KG is recalling its Tibial Component Modular orthopedic prosthesis due to a risk that blind screws cannot be loosened during surgery. This defect may prolong the operation by necessitating an intraoperative change in procedure.

How to tell if you have it

  • Brand: Waldemar Link
  • Product: Tibial Component Modular orthopedic prosthesis
  • Model Nos: Small, W 16-2817/32; Medium, W 16-2817/35; Large, W 16-2817/37
  • UDI-DI: 04026575370870 Small, W; 04026575370887 Medium, W; 04026575370894 Large, W
  • Lot Codes: 210308/0020, 210308/0035, 210222/0789, 151116/4741
  • Units affected: 3785

The hazard

According to the FDA, there is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.

Context

GovInfoNow's records show Waldemar Link GmbH & Co. KG 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 (February 11, 2026), and the Endo-Model Plateau Recall (January 12, 2026). Other recent recalls of similar products include the DURACON XL Angled Tibial Implants Recall (July 30, 2026), the Perip Screw Recall (December 19, 2025), and the Dental Implant Abutments Recall (March 27, 2026).

How to tell if you have this one

Check the model number on the prosthesis: Small (W 16-2817/32), Medium (W 16-2817/35), or Large (W 16-2817/37). Also look for the UDI-DI codes: 04026575370870 for Small, 04026575370887 for Medium, or 04026575370894 for Large.

  • Brand
    Waldemar Link
  • Category
    Medical device
FDA recall event · 4 products

All 4 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
    Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Israel Italy Latvia Libya Lithuania Mexico Netherlands Norway Pakistan Peru Philippines Poland Romania Saudi Arabia Slovakia Slovenia Spain Sudan Sweden Switzerland Thailand Turkey Ukraine United Arab Emirates Uruguy Vietnam
Recall numberProduct, codes & lots
Z-1377-2022Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.; UDI-DI 04026575316281 (Small) 04026575316298 (Medium) 04026575316304 (Large) Serial/Lot Numbers: 210420/0762 210426/0311 210426/0363 210426/0364 210426/0374 210504/2485 210504/2552 210504/2564 210504/2566 210510/2845 210510/2846 210602/0215 210602/0265 210602/0266 210602/1068 210602/2717 210602/2721 210602/2733 210602/2769 210629/0893 210629/0919 210629/0929 210629/0967 210629/0969 210629/1046 210629/1051 210629/1054 210629/2750 210802/0663 210802/0771 210802/0841 210907/2316 210907/2317 210913/0613 210913/0622 210913/0762 210913/0797 210913/0801 210913/0809 210913/2167 211025/0391 211025/2541 211025/2543 211025/2563 211102/0426 211102/0431 211115/0220 211115/1948 211115/2111
Z-1378-2022Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.; UDI-DI 04026575034727 X-Small, Right; 04026575034741 Small, Right; 04026575034758 Small, Left; 04026575164042 Medium, Right; 04026575164059 Medium, Left; 04026575164028 Large, Right; Serial/Lot Numbers: 200818/1709 200818/1720 201013/0291 200513/2160 200818/1732 200623/4154 200812/1511 210302/2440
Z-1379-2022Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07; UDI-DI: 04026575359202 Small, W; 04026575359219 Medium, W; 04026575359226 Large, W; Serial/Lot Numbers: 201002/1683 211025/1543 210202/0275 210302/0308 210314/1872 201002/1687
Z-1380-2022Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37; UDI-DI: 04026575370870 Small, W; 04026575370887 Medium, W; 04026575370894 Large, W; Serial/Lot Numbers: 210308/0020 210308/0035 210222/0789 151116/4741
Based on the official FDA remedy

What to do — step by step

  1. Check Model Number

    Identify the model number on the prosthesis: Small (W 16-2817/32), Medium (W 16-2817/35), or Large (W 16-2817/37).

  2. Verify UDI-DI Code

    Check the UDI-DI code: 04026575370870 for Small, 04026575370887 for Medium, or 04026575370894 for Large.

Where it went and when

Where it was distributed

Distributed in 15 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Nevada, New York, Ohio, Tennessee, Texas, Washington.

Recall timeline

FDA published this recall 57 days after the firm started it.

1. Firm started the recall: May 24, 202212. FDA classified it Class II: Jul 12, 202223. Published in FDA’s Enforcement Report: Jul 20, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-1380-2022 (May 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1380-2022 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA