SCIENCE & BIO MATERIALS recalls Bio 1 Granules for Filling ¿ 1 mm (2 cm¿)

Vials of implant bone granules may contain less product then specified on labeling.

On April 7, 2025 Science for Biomaterials issued a "Urgent Medical Device Recall" Notification via E-Mail. 1. Verify the presence of Lot 240781 in stock and its distribution, if applicable. 2. Destroy the product after taking photos of the vials contents for exchange. Send us a certificate of destruction. or return to DMs to us for exchange 3. Acknowledge receipt of this batch recall by returning the Response Form to regine.estaun@sbm-fr.com within 7 days of the date of receipt. .

• FDA enforcement recordOfficial FDA database entry for Z-1718-2025
• FDA 510(k) clearance · K021963The device's official FDA premarket clearance record
• FDA device classification · MQVOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3045The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find SCIENCE & BIO MATERIALSSearch 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.