Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog... recall (Exactech, Inc.)
Medical deviceClass IIOngoing
Summary: Exactech, Inc. is recalling Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X. Reason: Impactor handle may be missing cross-pin.
What is being recalled
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Why
Impactor handle may be missing cross-pin
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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 (states named: California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Wisconsin)
How to tell if yours is affected
All Lots/ UDI-DI: 10885862559166
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1510-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 3, 2026 |
| Reported | March 18, 2026 |
| Company | Exactech, Inc. |
| Company location | Gainesville, FL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 596 kits |
More recalls from Exactech, Inc. · all medical device recalls · recalls from February 2026