Class II — Potential Health Hazard

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

Navigator Surgical Kit Product Usage: Molded plastic tray used in Recalled by Biomet 3i, LLC Due to During recent revised sterilization validation testing, the included...

Date: July 22, 2013
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

Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

Quantity: 21

Why Was This Recalled?

During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

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