Exactech, Inc.: Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Exactech, Inc.
- Product
- Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
- Reason / hazard
- Impactor handle may be missing cross-pin
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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
- Recall initiated
- 2026-02-03
- Code info
- All Lots/ UDI-DI: 10885862559166
- Product quantity
- 596 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Gainesville
- State
- FL
- Country
- United States
- Event id
- 98376
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