⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Exactech, Inc.: Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product

Medical DevicesSource: FDA (device) · Date: 2025-11-26

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Exactech, Inc.
Product
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
Reason / hazard
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
Status
Ongoing
Distribution / sold at
U.S.: SC O.U.S.: N/A
Recall initiated
2025-09-05
Code info
Lot Code: Part Number: 321-59-42, UDI-DI: 10885862593009, Lot Number: 410398-013
Product quantity
1
Voluntary mandated
Voluntary: Firm initiated
City
Gainesville
State
FL
Country
United States
Event id
97588
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