Device product
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
Z-0536-2026
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 97588
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0536-2026
Official wording
Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
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
Derived failure modes
-
Unknown
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.