Class II — Potential Health Hazard

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

Prosthesis Head B Recalled by Waldemar Link GmbH & Co. KG (Mfg Site) Due to Inconsistent size terminology and color coding used on...

Date: July 15, 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

Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.

Quantity: 46 units

Why Was This Recalled?

Inconsistent size terminology and color coding used on labeling

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