UnratedMedical device recall · FDA · Published September 5, 2025
Equinoxe Ergo Adjustable Angle rTSA Reamer 46mm recall: Design updates not completed
Exactech recalls Equinoxe Ergo Adjustable Angle rTSA Reamer 46mm (model 321-59-46) due to incomplete design updates and performance testing. Products may not meet safety standards.
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
“Equinoxe Ergo Adjustable Angle rTSA Reamer 46mm recall: Design updates not completed.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51423-equinoxe-ergo-adjustable-angle-rtsa-reamer-46mm-recall-design-updates. Based on FDA recall #Z-0536-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0536-2026%22&limit=1).
The FDA announced on 2025-09-05 that Exactech, Inc. is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer (Model 321-59-46) because products may not conform to design and performance criteria due to incomplete updates and testing.
How to tell if you have it
Brand: Equinoxe Ergo
Product Name: Adjustable Angle rTSA Reamer, 46mm
Model/Catalog Number: 321-59-46
Lot Number: 410398-014
Part Number: 321-59-46
UDI: 10885862605535
The hazard
According to the FDA, the products have not completed design updates and performance testing before being released or distributed. Consequently, the products may not conform to required design and performance criteria.
Context
GovInfoNow's records show Exactech, Inc. has had 34 other recalls on record since 2017-06-23. Other recent recalls of similar products include Equinoxe Core Instrument Kit Recall (2026-02-03), Exactech Reverse Shoulder Humeral Liners Recall (2025-08-15), and Exactech Alteon XLE Hip Implant Recall (2024-12-31). Additional recent recalls of similar products include Forza Ti Spacer System Recall (2025-11-03), Philips Azurion 7 B20 System Recall (2026-01-26), and Olympus OER-ELITE Endoscope Reprocessor Tubes Recall (2026-03-25).
How to tell if you have this one
Check for the model number 321-59-46 on the product. The product is an adjustable angle rTSA reamer used in dental procedures.
Brand
Equinoxe Ergo
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
U.S.: SC O.U.S.: N/A
Recall number
Product, codes & lots
Z-0535-2026
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; Lot Code: Part Number: 321-59-42, UDI-DI: 10885862593009, Lot Number: 410398-013
Z-0536-2026
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; Lot Code: Part Number: 321-59-46, UDI: 10885862605535, Lot Number: 410398-014
Z-0537-2026
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component; Lot Code: Part Number: 301-11-11, UDI: 10885862592934, Lot Number: 410413-001
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the model number 321-59-46 on the product to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed in South Carolina.
Listed by the agency
Not listed
FDA distribution: “U.S.: SC O.U.S.: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: South Carolina.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0536-2026 (September 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0536-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.