IsoTis OrthoBiologics recalls

Recall found. IsoTis OrthoBiologics is named in FDA Class II recall Z-2820-2026 covering OsteoBallast. Hazard: 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. Identifying details: REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550. Status: Ongoing.

Models with recalls

OsteoBallast (1)

All IsoTis OrthoBiologics recalls

FDA Class II · Medical device · August 5, 2026

OsteoBallast recall — IsoTis OrthoBiologics, Inc.

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…

Official ID Z-2820-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.