Class II — Potential Health Hazard

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

Equinoxe Humeral Stem Recalled by Exactech, Inc. Due to Potential for incorrect Instructions For Use (IFU) included...

Date: November 9, 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

Equinoxe Humeral Stem, Primary, Press Fit, 11mm

Quantity: 14 devices

Why Was This Recalled?

Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

Where Was This Sold?

This product was distributed to 3 states: CA, KS, OH

Affected (3 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