Class II — Potential Health Hazard

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

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer Recalled by Exactech, Inc. Due to Due to products that have not completed design...

Date: September 5, 2025
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

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component

Quantity: 1

Why Was This Recalled?

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

Where Was This Sold?

This product was distributed to 1 state: SC

Affected (1 state)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