Recalls / —

—#218661

Product

Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X

FDA product code

HWA — Impactor

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

All Lots/ UDI-DI: 10885862559166

Why it was recalled

Impactor handle may be missing cross-pin

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On February 5, 2026, Exactech issued a Urgent Medical Device Recall Notification Expansion to affected consignees. Initial notification was issued on January 23, 2026. Exactech asked consignees to take the following actions: 1. IMMEDIATELY CEASE USE AND DISTRIBUTION. Stop using or distributing any Ergo Impactor Handle (321-09-05) from the affected lots. 2. CAREFULLY REVIEW THIS NOTIFICATION. Ensure all personnel understand the issue and required actions. 3. IDENTIFY, QUARANTINE AND RETURN 4. EXTEND THIS INFORMATION. Communicate this notice to all accounts that were shipped or may have been shipped affected units. 5. Response Form. A mandatory response form is attached. Please complete and return it to recalls@advita.com within 5 business days.

Recalling firm

Firm

Exactech, Inc.

Address

2320 Nw 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern

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

Timeline

Recall initiated

2026-02-03

Posted by FDA

2026-03-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #218661. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.