Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-1510-2026 · Posted 2026-03-09

Recalling FirmExactech, Inc.
Recall StatusOpen, Classified
Product CodeHWA
Date Initiated2026-02-03
Product Quantity596 kits

Reason for Recall

Impactor handle may be missing cross-pin

Firm Action

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 [email protected] within 5 business days.

Root Cause

Under Investigation by firm

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑