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Lower risk Medical device recall · FDA · Published March 18, 2021

Waldemar Link Recalls Left Knee Prosthesis Segment for Size 3 - Device May Not Meet

Waldemar Link recalls left knee prosthesis segment size 3 due to potential failure to meet specifications. Affected units include specific model and serial numbers. Consumers should contact the company for details.

🇺🇸 FDA recall #Z-2047-2023Medical 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 a specific left knee prosthesis segment for size 3 because it may not meet required specifications. This could affect the safety and proper function of the implant. Read more at govinfonow.com/recall/63034-waldemar-link-recalls-left-knee-prosthesis-segment-for-size-3.

Source Summary by GovInfoNow · govinfonow.com/recall/63034-waldemar-link-recalls-left-knee-prosthesis-segment-for-size-3 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2047-2023

Cite this page

“Waldemar Link Recalls Left Knee Prosthesis Segment for Size 3 - Device May Not Meet.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63034-waldemar-link-recalls-left-knee-prosthesis-segment-for-size-3. Based on FDA recall #Z-2047-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2047-2023%22&limit=1).

Waldemar Link GmbH & Co. KG recalled LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left on March 18, 2021, according to the FDA. The firm stated device segments may not meet specifications.

How to tell if you have it

  • Brand: Waldemar Link
  • Product: LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
  • Item No.: 15/2973/06
  • UDI-DI: 04026575340736
  • Quantity: 22 units

The hazard

The firm discovered through customer complaints that device segments may not meet specifications.

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 EMPOWR 3D Knee Implants Have Incorrect Labeling (January 15, 2026), U2 Total Knee System: Risk of Improper Assembly Due to Manufacturing Defect (May 20, 2026), and U2 Total Knee System PSA Box Trial: Incomplete Screw Assembly Risk (May 20, 2026).

How to tell if you have this one

Check if your knee prosthesis is the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left with item number 15/2973/06 and UDI-DI 04026575340736.

  • 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: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-2046-2023LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right; Item No. 15-2973/05; UDI-DI: 04026575340699.21 units
Z-2047-2023LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left; Item No. 15/2973/06; UDI-DI: 04026575340736.22 units
Z-2048-2023LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right; Item No. 15-2979/01; UDI-DI: 04026575328093.16 units
Z-2049-2023LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left; Item No. 15-2979/02; UDI-DI: 04026575328109.13 units
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Waldemar Link for specific instructions on whether your prosthesis is affected and next steps.

Where it went and when

Where it was distributed

Distributed in 8 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: not listedOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: 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: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, Texas.

Recall timeline

FDA published this recall 2.3 years after the firm started it.

1. Firm started the recall: Mar 18, 202112. FDA classified it Class II: Jun 30, 202323. Published in FDA’s Enforcement Report: Jul 5, 2023320212023
  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.

✎ GovInfoNow

Questions people ask

Is there a risk of serious injury from this prosthesis?

The recall states the segments may not meet specifications, but no specific injury risk is mentioned. The hazard level is low risk.

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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-2047-2023 (March 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2047-2023 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