OsteoBallast — Class II medical device recall Z-2820-2026
Ongoing recall by IsoTis OrthoBiologics, Inc., reported 2026-08-05, distributed nationwide. Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender i
| Recall number | Z-2820-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | IsoTis OrthoBiologics, Inc., Irvine, CA, United States |
| Recall initiated | 2026-07-02 |
| Classified | 2026-07-28 |
| Reported by FDA | 2026-08-05 |
| Distributed | Nationwide (US) |
| Quantity | 98 |
| UPC / GTIN / UDI-DI | 10889981149314, 10889981149352 |
| Lot numbers | 181550, 56800095/10889981149352/181559 |
| Model numbers | 02-8000-095, 56800095 |
Product
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
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 ¿ 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2820-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.