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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

LinkSymphoKnee Tibial Components Recalled for Incorrect Security Screws

Agency Publication Date: September 8, 2025
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Summary

Waldemar Link GmbH & Co. KG is recalling 8 units of the LinkSymphoKnee System Tibial Component because they were manufactured with two uncoated security screws instead of the required coated screws. This manufacturing error involves the Modular, Symmetric, Size 5 version of the component. This defect may affect the structural integrity or performance of the knee implant. Patients who have received this implant or healthcare providers who stock it should contact the manufacturer or their orthopedic surgeon immediately.

Risk

The use of uncoated screws in a modular knee system may lead to increased wear, corrosion, or mechanical failure of the implant over time. While no specific injuries were mentioned in the recall notice, a failing implant could require additional surgery to repair or replace the component.

What You Should Do

  1. This recall involves the LinkSymphoKnee System Tibial Component (Modular, Symmetric, Size 5) identified by REF number 880-100/50 and UDI-DI 04026575251278.
  2. Check the serial number on your device packaging or medical records to see if it matches one of the following: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, or 210125/2273.
  3. Stop using the recalled device and do not implant any units currently in inventory.
  4. Contact your healthcare provider, surgeon, or the manufacturer Waldemar Link GmbH & Co. KG to arrange for the return, replacement, or correction of the affected components.
  5. For additional information, call the FDA Consumer Complaint hotline at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed
Variants: Size 5, Modular, Symmetric, Cemented, Fixed
Model / REF:
880-100/50
Serial Numbers:
210125/2259
210125/2262
210125/2268
210125/2260
210125/2264
210125/2270
210125/2272
210125/2273
UDI:
04026575251278

Quantity affected: 8 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97383
Status: Active
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Sold By: Hospitals; Surgical Centers; Orthopedic Clinics
Manufactured In: Germany
Units Affected: 8 units
Distributed To: Colorado, Indiana, New Jersey, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.