Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catal…

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

On 09/05/2025, the firm emailed an "URGENT MEDICAL DEVICE RECALL NOTICE" to customers informing that, during routine inventory review, it was discovered that the a number of parts/products, which were pending design verification testing were incorrectly placed in active internal inventory rather than designated quarantine locations. Several part/products were distributed to customers. Customers are instructed to: "Carefully review this notification to ensure that they fully understand the issue and all actions required. "Immediately identify, quarantine, and return any of the subject devices in their inventory and/or customer s inventory. "Stop and cease use of any affected devices. "Notify all their accounts that may have received these products and extend this recall notice, including the Description of Issue and Potential Clinical Impact, to them. "Complete and Return the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com. For questions or assistance - contact Recall Support Team at recalls@exac.com

• FDA enforcement recordOfficial FDA database entry for Z-0537-2026
• FDA 510(k) clearance · K042021The device's official FDA premarket clearance record
• FDA device classification · PHXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3660The 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.