FDA-Device2026-03-18Class II
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Exactech, Inc.
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-1510-2026Original summary
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X Impactor handle may be missing cross-pin All Lots/ UDI-DI: 10885862559166 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 Affected quantity: 596 kits
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