Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Nu…

Impactor handle may be missing cross-pin

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.

• FDA enforcement recordOfficial FDA database entry for Z-1509-2026
• FDA device classification · HWAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.4540The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Exactech, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.