IsoTis OrthoBiologics, Inc. — OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 2, 2026
US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
What's affected?
- Product
- OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
- Lot code
- 56800095/10889981149352/181559
Additional details
REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 98.
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