Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer
- Recalling company
- Exactech, Inc.
- 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
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 5, 2025
- Reported
- Nov 26, 2025
- Distribution
- U.S.: SC O.U.S.: N/A
- Status
- Ongoing
- Quantity
- 1
- Lot / codes
- Lot Code: Part Number: 321-59-46, UDI: 10885862605535, Lot Number: 410398-014
- Company location
- Gainesville, FL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0536-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0536-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.