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Recall Observatory FDA recall evidence

Device 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

Z-0535-2026

September 05, 2025

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 97588
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0535-2026

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: 321-59-42, UDI-DI: 10885862593009, Lot Number: 410398-013

Distribution pattern: U.S.: SC O.U.S.: N/A

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.