Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Summary
The FDA issued a Class II for Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog by Exactech, Inc.. Reason: Impactor handle may be missing cross-pin.
Details
Source
Device Recall
External ID
Z-1510-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Lot/Code Info: All Lots/ UDI-DI: 10885862559166
Quantity Affected: 596 kits
Reason for Recall
Impactor handle may be missing cross-pin
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
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-03
Company
Gainesville, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Exactech, Inc. has 110 FDA actions in our database, including 97 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Exactech, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Exactech, Inc. have FDA actions?
Exactech, Inc. has 110 FDA actions in our database, including 97 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1510-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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