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

Recall date

February 3, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1509-2026

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

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

Why it was recalled

Impactor handle may be missing cross-pin

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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