Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number...
FDA Recall #Z-0536-2026 — Class II — September 5, 2025
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
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.
Recalling Firm
Exactech, Inc. — Gainesville, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1
Distribution
U.S.: SC O.U.S.: N/A
Code Information
Lot Code: Part Number: 321-59-46, UDI: 10885862605535, Lot Number: 410398-014
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated