Class II — Potential Health Hazard

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

Straumann¿ Emdogain 015 Recalled by Straumann Manufacturing, Inc. Due to A change regarding the shelf life of a...

Date: March 23, 2018
Company: Straumann Manufacturing, Inc.
Status: Terminated
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 Straumann Manufacturing, Inc. directly.

Affected Products

Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099

Quantity: 3046

Why Was This Recalled?

A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Straumann Manufacturing, Inc.

Straumann Manufacturing, Inc. has 11 total recalls tracked by RecallDetector.

Related Recalls

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