Exactech, Inc.: Device Recall

Recall #Z-0536-2026 · 09/05/2025

Class II: Risk

Recall Details

Recall Number: Z-0536-2026
Classification: Class II
Product Type: Device
Recalling Firm: Exactech, Inc.
Status: Ongoing
Date Initiated: 09/05/2025
Location: Gainesville, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1

Reason for Recall

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

Product Description

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

Distribution Pattern

U.S.: SC O.U.S.: N/A

Other Recalls by Exactech, Inc.

Class II: Risk 09/05/2025

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Class II: Risk 09/05/2025

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Class II: Risk 08/15/2025

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Class II: Risk 08/15/2025

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Class II: Risk 12/31/2024

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

View all recalls by Exactech, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.