FDAHealthSeptember 5, 2025
Exactech, Inc. — 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:
⚠️ Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Is this relevant to me?
- Geography
- SC
- Source agency
- FDA
- Category
- Health
- Published
- September 5, 2025
U.S.: SC O.U.S.: N/A
What's affected?
- 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
- Brand
- Exactech, Inc.
- Lot code
- Part
Additional details
Lot Code: Part Number: 321-59-46, UDI: 10885862605535, Lot Number: 410398-014
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1.
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