FDA recall Z-0535-2026

Product

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

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

Key facts

Status

Ongoing

Initiation date

2025-09-05

Report date

2025-11-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0535-2026