Class II — Potential Health Hazard

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

Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: Recalled by Biomet 3i, LLC Due to Pouches may not have been sealed during packing.

Date: November 25, 2015
Company: Biomet 3i, LLC
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 Biomet 3i, LLC directly.

Affected Products

Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental implants

Quantity: 1,648,273 devices (all products subject to this recall.

Why Was This Recalled?

Pouches may not have been sealed during packing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Biomet 3i, LLC

Biomet 3i, LLC has 222 total recalls tracked by RecallDetector.

Related Recalls

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