Drug recall
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF…
FDA recall event 99332 · Class II · IsoTis OrthoBiologics, Inc.
Key facts
| Event ID | 99332 |
|---|---|
| Recall numbers | Z-2820-2026 |
| Recalling firm | IsoTis OrthoBiologics, Inc. |
| Product type | Devices |
| Products | OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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 ¿… |
| Initiation date | Jul 2, 2026 |
| Report date | Aug 5, 2026 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3001503333 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: