Class II — IsoTis OrthoBiologics, Inc.
| Recalling firm | IsoTis OrthoBiologics, Inc. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095 |
| Quantity | 98 |
| Distribution | US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH. |
| Initiated | 2026-07-02 |
| Classified | 2026-07-28 |
| Recall number | Z-2820-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — IsoTis OrthoBiologics, Inc. (Z-2820-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99332/
Alerts for IsoTis OrthoBiologics, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.