Class II

Medical Device Recall: 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

Exactech, Inc. · September 5, 2025

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.

Distribution

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

States Affected

SC

Quantity Affected

1

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0536-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Exactech, Inc. Medical Device Recall: 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 | SafeCheck