FDA recall, , Moderate risk
Exactech Equinoxe Ergo and Equinoxe Core Instrument Kits
The Equinoxe Core Instrument Kit and Ergo Modular Impactor Handle may have a missing cross-pin in the impactor handle.
Summary by Recall Canary from the FDA notice
What happened
Exactech, Inc. of Gainesville, Florida recalled the Ergo Modular Impactor Handle and Equinoxe Core Instrument Kit because the impactor handle may be missing a cross-pin. The company began the recall on February 3, 2026, and the FDA added it to the Enforcement Report on March 9, 2026.
The products were distributed in 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 and OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
2 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Equinoxe Ergo Ergo Modular Impactor Handle
- UDI-DI
- 10885862557674
- Model/Catalog number
- 321-09-05
Equinoxe Core Instrument Kit
- UDI-DI
- 10885862559166
- Model/Catalog number
- KIT-311X
- Lot code
- All Lots/ UDI-DI: 10885862559166
Recall details
- Company began the recall
- Sold in
- 24 states
US: California Colorado Florida Georgia HI ID Illinois IN Kansas Kentucky Louisiana Massachusetts MD ME Minnesota Nevada New York Ohio OK PR South Carolina Tennessee Texas Virginia Wisconsin OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia
- Company
- Exactech, Inc.Gainesville, Florida
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98376
- Recall numbers
- Z-1509-2026 to Z-1510-2026
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
