FDAHealthFebruary 3, 2026
Exactech, Inc. — Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
⚠️ Impactor handle may be missing cross-pin
Is this relevant to me?
- Geography
- 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
- Source agency
- FDA
- Category
- Health
- Published
- February 3, 2026
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
What's affected?
- Product
- Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
- Brand
- Exactech, Inc.
- Lot code
- Part
Additional details
Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details)
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 120 units.
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