Class II — Potential Health Hazard

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

Vilex Recalled by Vilex In Tennessee Inc Due to Incidence of breakage is higher than expected.

Date: April 22, 2015
Company: Vilex In Tennessee 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 Vilex In Tennessee Inc directly.

Affected Products

Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

Quantity: 7 units

Why Was This Recalled?

Incidence of breakage is higher than expected.

Where Was This Sold?

This product was distributed to 4 states: MD, MS, PA, TX

Affected (4 states)Not affected

About Vilex In Tennessee Inc

Vilex In Tennessee Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

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