Exactech, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0536-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 5, 2025

Date Posted: November 26, 2025

Recall Number: Z-0536-2026

Event ID: 97588

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.

Status: Ongoing

Product Quantity: 1

Code Information:

Lot Code: Part Number: 321-59-46, UDI: 10885862605535, Lot Number: 410398-014

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated