Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Endo Model Knee Fusion Nail SK Recalled by Waldemar Link GmbH & Co. KG (Mfg Site) Due to The device has been delivered with a preassembled...

Date: November 10, 2025
Company: Waldemar Link GmbH & Co. KG (Mfg Site)
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Waldemar Link GmbH & Co. KG (Mfg Site) directly.

Affected Products

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.

Quantity: 18 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 3 states: AL, GA, TX

Affected (3 states)Not affected

About Waldemar Link GmbH & Co. KG (Mfg Site)

Waldemar Link GmbH & Co. KG (Mfg Site) has 62 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report