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
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
- Recall initiated
- 2026-07-02
- Code info
- REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550
- Product quantity
- 98
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Irvine
- State
- CA
- Country
- United States
- Event id
- 99332
Free daily digest + "My products" watchlist