IsoTis OrthoBiologics, Inc. recalls OsteoBallast
- Recalling company
- IsoTis OrthoBiologics, Inc.
- Product
- OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 2, 2026
- Reported
- Aug 5, 2026
- Distribution
- US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
- Status
- Ongoing
- Quantity
- 98
- Lot / codes
- REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550
- Company location
- Irvine, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2820-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2820-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.