Home / Recalls / Medical Devices
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software V
Recalled November 26, 2025 · FDA recall Z-0536-2026 · Exactech
Hazard
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. · FDA Class II
Units
1
Sold at
U.S.: SC O.U.S.: N/A
Description
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
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
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →