FDA-Device2026-03-18Class IIPROCESSING DEFECT
Exactech Equinoxe Ergo Impactor Handle recalled for missing cross-pin
Stop using Exactech Equinoxe Ergo impactor handles
Exactech's Equinoxe Ergo Ergo Modular Impactor Handle (model 321-09-05) may be missing an internal cross-pin. This defect could affect the handle's stability or function during surgical use. The recall affects 120 units distributed across the US and nine other countries.
- Stop using the affected impactor handle immediately if you have one
- Check the lot number against the product information spreadsheet available from Exactech or the FDA
- Contact Exactech for instructions on inspection, repair, or replacement
- Report any injuries or unsafe incidents to the FDA MedWatch program
Hazard
Impactor handle may be missing cross-pin
Sold states
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
Affected count
120 units
Manufactured in
2320 Nw 66th Ct, N/A, Gainesville, FL, United States
Products
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1509-2026More Exactech, Inc. recalls
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