Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Ver…

Recall date

September 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0535-2026

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component