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Use caution Medical device recall · FDA · Published July 31, 2025

Waldemar Link LinkSymphoKnee Tibial Component Recall: Incorrect Security Screws

Waldemar Link recalls some LinkSymphoKnee Tibial Components with uncoated security screws. These components may not hold securely, risking joint instability. Affected units have specific serial numbers and REF numbers.

🇺🇸 FDA recall #Z-2541-2025Medical deviceWaldemar Link ›
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Recalling firmWaldemar Link GmbH & Co. KG (Mfg Site)Oststr. 4-10 · Norderstedt, Germany
✎ GovInfoNow plain-language explainer

What happened, in plain English

Waldemar Link is recalling certain LinkSymphoKnee Tibial Components that were made with two uncoated security screws instead of the correct coating. This could cause the component to become loose or fail during use, potentially leading to joint instability or injury. Read more at govinfonow.com/recall/51712-waldemar-link-linksymphoknee-tibial-component-recall-incorrect-security-screws.

Source Summary by GovInfoNow · govinfonow.com/recall/51712-waldemar-link-linksymphoknee-tibial-component-recall-incorrect-security-screws · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2541-2025

Cite this page

“Waldemar Link LinkSymphoKnee Tibial Component Recall: Incorrect Security Screws.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51712-waldemar-link-linksymphoknee-tibial-component-recall-incorrect-security-screws. Based on FDA recall #Z-2541-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2541-2025%22&limit=1).

Why it’s dangerous

The recalled components were manufactured with two uncoated security screws instead of the correct coated screws. This could cause the component to become loose or fail during use, potentially leading to joint instability or injury.

Who’s affected

Patients who have received the recalled LinkSymphoKnee Tibial Components with the specific serial numbers listed in the recall are affected. Orthopedic surgeons and patients using these components are at risk of joint instability.

How to tell if you have this one

Check the serial numbers listed: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, 210125/2273. Also check the REF numbers: 880-100/50.

  • Brand
    Waldemar Link
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Component Serial Numbers

    Look for the specific serial numbers listed in the recall: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, 210125/2273.

  2. Contact Manufacturer

    Reach out to Waldemar Link for further instructions on how to address the issue with the recalled components.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Colorado, Indiana, New Jersey, Texas.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Jul 31, 202512. FDA classified it Class II: Sep 8, 202523. Published in FDA’s Enforcement Report: Sep 17, 202532025
  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-2541-2025 (July 31, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2541-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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