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Home › FDA recalls › Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impact
CLASS II · ModerateFDA

Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle

📅 Feb 3, 2026 · 📍 CA, CO, FL, GA, HI, ID, IL, IN +17
Recalling company
Exactech, Inc.
Product
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Reason
Impactor handle may be missing cross-pin
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Feb 3, 2026
Reported
Mar 18, 2026
Distribution
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
Status
Ongoing
Quantity
120 units
Lot / codes
Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details)
Company location
Gainesville, FL
Recall type
Voluntary: Firm initiated
Recall number
Z-1509-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1509-2026 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.