IsoTis OrthoBiologics, Inc. recalls OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix

Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

An Urgent Medical Device Recall notice was issued via email 11/27/2024. The notice advised consignees to either use the product by the expiration date listed in the notice or return the affected part(s) using provided shipping label and complete and return the Acknowledgement and Receipt Form as soon as possible. Direct questions regarding this matter to Danielle Becker at danielle.becker@seaspine.com or Danielle Nelson-Archer at danielle.nelson-archer@seaspine.com.

• FDA enforcement recordOfficial FDA database entry for Z-0955-2025
• FDA 510(k) clearance · K242273The 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 IsoTis OrthoBiologics, 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.