Omnia Medical recalls TiBrid Stand Alone Intervertebral Body Fusion Device

Failure of fusion system instruments in the field.

Consignees were called on or around 8/1/2024 to notify them of this recall of instruments. Affected instruments were to be sent back to Omnia Medical and replaced with instruments that underwent rework in the form of design changes aimed at increasing their durability.

• FDA enforcement recordOfficial FDA database entry for Z-2556-2025
• FDA 510(k) clearance · K203207The device's official FDA premarket clearance record
• FDA device classification · OVDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3080The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Omnia MedicalSearch 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.