IsoTis OrthoBiologics, Inc. recalls OsteoBallast

Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 ¿ 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.

On 7/2/2026, recall notices were emailed to customers informing them of the following: Orthofix does not recommend removal or revision of implanted devices containing product from the affected lots. Patients should continue to be managed according to the treating surgeon's standard clinical practice and routine follow-up schedule. Surgeons should monitor for signs or symptoms consistent with delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth and manage patients as clinically indicated. If the procedure was performed in accordance with the surgical technique and the intended intraoperative objectives were achieved, no additional patient management beyond routine postoperative care and clinical follow-up described in the Instructions for Use is recommended. The standard postoperative precautions described in the Instructions for Use, including activity restrictions and weight-bearing recommendations, should continue to be followed at the discretion of the treating surgeon. 1) Identify, and quarantine unused product and work with firm to facilitate product return. 2) Complete and return the attached Acknowledgement and Receipt Form 3) This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. Any product complaints should be reported to Orthofix at complaints@orthofix.com. For questions regarding this recall, including product return, replacement, or credit, please contact Audrey Mudderman, Senior Post Market Surveillance Specialist, at audreymudderman@orthofix.com

• FDA enforcement recordOfficial FDA database entry for Z-2820-2026
• FDA 510(k) clearance · K172130The 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.