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 Replacement Plateau Recalled by Waldemar Link GmbH & Co. KG (Mfg Site) Due to The potential for an implant with a plateau...

Date: January 12, 2026
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 Replacement Plateau; Item Number: 15-8521/11;

Quantity: 7 units (OUS only)

Why Was This Recalled?

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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