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Equinoxe Core Instrument Kit
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MEDICAL DEVICE RECALLMODERATE

Equinoxe Core Instrument Kit

Exactech recalls Equinoxe Core Instrument Kit and Ergo Impactor Handle over missing cross-pin risk.

What to do

Stop using the affected devices immediately. Contact Exactech for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-1510-2026
Agency
FDA
Firm
Exactech, Inc.
Recall ID
98376
Status
ONGOING

Why it was recalled

Exactech is recalling the Equinoxe Core Instrument Kit (model KIT-311X) and the Ergo Modular Impactor Handle (model 321-09-05) because the impactor handle may be missing a cross-pin, which could cause the handle to detach during surgery and potentially injure the patient or surgical staff.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DIModel/Catalog number
Equinoxe Ergo Ergo Modular Impactor HandleZ-1509-202610885862557674321-09-05
Equinoxe Core Instrument KitZ-1510-202610885862559166KIT-311X

Where it was sold

Distributed in California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Nevada, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, and Wisconsin.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-07-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification