🔍 RecallPedia

Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.

Class I - Dangerous
🏥 Medical Devices Recalled: November 10, 2025 Waldemar Link GmbH & Co. KG (Mfg Site) Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Waldemar Link GmbH & Co. KG (Mfg Site)
Reason for Recall:
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.

Product Codes/Lot Numbers:

Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;

Distribution:

Distributed in: US, AL, GA, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0890-2026

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