Class II — Potential Health Hazard

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

The Vantage Total Ankle Tibial Insert Recalled by Exactech, Inc. Due to The Vantage Total Ankle Tibial Insert, Fixed Bearing,...

Date: August 10, 2020
Company: Exactech, Inc.
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 Exactech, Inc. directly.

Affected Products

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.

Quantity: 11 units

Why Was This Recalled?

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.

Where Was This Sold?

This product was distributed to 4 states: CO, FL, OK, PA

Affected (4 states)Not affected

About Exactech, Inc.

Exactech, Inc. has 211 total recalls tracked by RecallDetector.

Related Recalls

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