OsteoCove Putty — Class II medical device recall Z-0919-2025
Ongoing recall by IsoTis OrthoBiologics, Inc., reported 2025-01-22, distributed nationwide. Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with t
| Recall number | Z-0919-2025 |
|---|---|
| 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 | 2025-01-15 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 145 |
| UPC / GTIN / UDI-DI | 10889981308933, 10889981309022 |
| Lot numbers | 179604R18, 180054, 180054R18, 180075, 180075R18, 180299, 180370, 180484 |
| Model numbers | 02-9200-01, 02-9200-013, 56920013 |
| Expiration dates | 2024-12-28, 2025-08-28, 2025-11-28, 2026-01-28, 2026-02-28 |
Product
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Reason for recall
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
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-0919-2025. 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.