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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

Endo Model Knee Fusion Nail SK Recalled for Incorrect Locking Screw Assembly

Agency Publication Date: December 9, 2025
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Summary

Waldemar Link GmbH & Co. KG is recalling 18 units of the Endo Model Knee Fusion Nail SK modular coupling component. These devices were delivered with a preassembled locking screw that was inserted from the wrong side into the femoral component's taper. If you are a healthcare provider using these limb salvage replacement devices, contact the manufacturer or your distributor to arrange for a return, replacement, or correction.

Risk

The incorrectly inserted locking screw may compromise the stability and function of the knee fusion nail. This defect could lead to device failure, surgical delays, or the need for revision surgery to correct the assembly error.

What You Should Do

  1. This recall involves the Endo Model Knee Fusion Nail SK, Coupling Component (right, modular, 68 mm, Taper 10/12) identified by item number 15-0028/08 and lot number 2535004.
  2. Stop using the recalled device immediately.
  3. Contact Waldemar Link GmbH & Co. KG or your distributor to arrange for the return, replacement, or correction of the affected equipment.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

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: Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component (68 mm, right, modular, Taper 10/12)
Variants: Right, Modular, L= 68 mm, Taper 10/12
Model / REF:
15-0028/08
Lot Numbers:
2535004
UDI:
04026575175222

Knee component of limb salvage replacement devices.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97971
Status: Active
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Sold By: Medical distributors; Surgical centers; Hospitals
Manufactured In: Germany
Units Affected: 18 units
Distributed To: Alabama, Georgia, 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.