FDAFDA · Food and drugs·Recall number Z-2820-2026
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Published August 5, 2026 · Recall initiated: July 2, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- IsoTis OrthoBiologics, Inc.
- Distributor
- US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
- Lot
- REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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