Class II — Potential Health Hazard

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

Exactech Equinoxe Shoulder System Recalled by Exactech, Inc. Due to Exactech has received 3 complaints for 4 devices...

Date: November 21, 2023
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

Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35

Quantity: N/A

Why Was This Recalled?

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Where Was This Sold?

This product was distributed to 16 states: AR, FL, GA, IL, IN, KY, ME, MD, MN, NV, NH, NY, SC, TN, TX, VA

Affected (16 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