Z-0536-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 26, 2025
- Initiation Date
- September 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
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.
Distribution Pattern
U.S.: SC O.U.S.: N/A
Code Information
Lot Code: Part Number: 321-59-46, UDI: 10885862605535, Lot Number: 410398-014