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

Exactech, Inc.: Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05

Medical DevicesSource: FDA (device) · Date: 2026-03-18

Read the official notice at FDA (device) →

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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: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Reason / hazard
Impactor handle may be missing cross-pin
Classification
Class II
Status
Ongoing
Distribution / sold at
US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia
Recall initiated
2026-02-03
Code info
Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details)
Product quantity
120 units
Voluntary mandated
Voluntary: Firm initiated
City
Gainesville
State
FL
Country
United States
Event id
98376
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