OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix — Class II medical device recall Z-0955-2025
Ongoing recall by IsoTis OrthoBiologics, Inc., reported 2025-01-22, distributed nationwide. Incorrect expiration date listed on the outer box, which does not align with the correct expiration date liste
| Recall number | Z-0955-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | IsoTis OrthoBiologics, Inc., Irvine, CA, United States |
| Recall initiated | 2024-11-27 |
| Classified | 2025-01-16 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 22 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10889981055820 |
| Lot numbers | 1031825, 1031907 |
| Model numbers | 56300100 |
| Expiration dates | 2024-11-28, 2025-03-28, 2025-07-28, 2025-11-28 |
Product
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Reason for recall
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
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-0955-2025. 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.