FDA Designates IsoTis OrthoBiologics Recall as Class II
On August 5, 2026, the FDA classified the ongoing recall of 98 bone graft extender products as a Class II action.
3 reports on this incident · first at Aug 20, 2026, 6:53 a.m. ET
Earlier reports
Aug 20, 2026, 7:11 a.m. ET
FDA Closes IsoTis OrthoBiologics Bone Graft Extender Recall
The U.S. Food and Drug Administration has closed recall Z-2820-2026 regarding bone graft extender products manufactured by IsoTis OrthoBiologics, Inc. of Irvine, California, meaning the agency considers the recall carried out. The recall action was initiated on July 2, 2026, and officially reported on August 5, 2026.
The Class II recall affected 98 units distributed nationwide across AK, NJ, TN, AR, CA, WA, and OH. According to FDA guidance, Class II is the agency's middle category, used where a product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. FDA enforcement records note that the database contains no other enforcement actions for IsoTis OrthoBiologics, Inc.
For anyone who still has the product, the recalled items include OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095, and Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095. Identifying codes list REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 and 02-8000-095/10889981149314/181559, 181550. The units—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.
Aug 20, 2026, 6:53 a.m. ETFirst report
IsoTis OrthoBiologics Recalls Bone Graft Extender Products Over Incorrect Fill Volumes
On August 5, 2026, the FDA reported an ongoing Class II recall initiated on July 2, 2026, by Irvine-based IsoTis OrthoBiologics, Inc. for 98 units of bone graft extender products. The affected items are OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095, and Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095. Identifying codes listed in FDA records include REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 and 02-8000-095/10889981149314/181559, 181550. Distribution was nationwide in the states of AK, NJ, TN, AR, CA, WA, and OH. According to FDA enforcement report recall number Z-2820-2026, demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis was 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). The agency reported that this may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth. Class II is defined by the FDA as a classification used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. FDA records list no other enforcement actions for IsoTis OrthoBiologics, Inc.
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- Version 120 Aug 2026, 10:53current
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- Version 120 Aug 2026, 11:22current
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- Version 120 Aug 2026, 11:11current
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