Class II — Potential Health Hazard

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

Tibial Alignment Guide Recalled by Exactech, Inc. Due to Exactech is recalling the Tibial Alignment Guide because...

Date: July 13, 2018
Company: Exactech, 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 Exactech, Inc. directly.

Affected Products

Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.

Quantity: 7 units

Why Was This Recalled?

Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.

Where Was This Sold?

This product was distributed to 7 states: CA, FL, NY, OH, OK, SC, TX

Affected (7 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