Device product
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Z-1510-2026
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 98376
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 596 kits
- Official record key
device-enforcement:Z-1510-2026
Official wording
Reason: Impactor handle may be missing cross-pin
Code information: All Lots/ UDI-DI: 10885862559166
Distribution pattern: 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
Derived failure modes
-
Unknown
Impactor handle may be missing cross-pin