FDA-Device2026-03-18Class IIPROCESSING DEFECT
Exactech Equinoxe Core Instrument Kit recalled for missing cross-pin on impactor handle
Stop using Exactech Equinoxe instrument kits
Exactech has recalled 596 Equinoxe Core Instrument Kits (model KIT-311X) because the impactor handle may be missing a cross-pin. This defect could affect the handle's stability during surgical use. No injuries have been reported.
- Stop using affected kits immediately if you have them in your facility
- Check your inventory for model KIT-311X with the affected UDI-DI: 10885862559166
- Contact Exactech for instructions on inspection, repair, or replacement
- Document which patients may have been affected and report to your quality/compliance team
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
596 kits
Manufactured in
2320 Nw 66th Ct, N/A, Gainesville, FL, United States
Products
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1510-2026More Exactech, Inc. recalls
- FDA-Device2026-03-18Exactech Equinoxe Ergo Impactor Handle recalled for missing cross-pin
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