← FDA ENFORCEMENT
Z-1510-2026Class II
Exactech, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Exactech, Inc.
Product type
Device
Status
Ongoing
Report date
2026-03-18
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
Firm state
FL
Product quantity
596 kits
Initiated by
Voluntary: Firm initiated
Reason for recall
Impactor handle may be missing cross-pin
Product description
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Code / lot info
All Lots/ UDI-DI: 10885862559166
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →