FDA Medical devices recall ·
Equinoxe Product Name: Equinoxe Core Instrument Kit Model recall
- Recall number
- Z-1510-2026
- Date
- (initiated February 3, 2026)
- Company / brand
- Exactech, Inc.
2320 Nw 66th Ct, Gainesville, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 596 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Why was it recalled?
Impactor handle may be missing cross-pin
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
States: California Florida Georgia Illinois Kansas Kentucky Maryland Minnesota Nevada New York Puerto Rico South Carolina Tennessee Texas Virginia Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1510-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.