Bio 1 Granules for Filling ¿ 1 mm — Class II medical device recall Z-1718-2025
Ongoing recall by SCIENCE & BIO MATERIALS, reported 2025-05-14, distributed nationwide. Vials of implant bone granules may contain less product then specified on labeling.
| Recall number | Z-1718-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCIENCE & BIO MATERIALS, Lourdes, N/A, France |
| Recall initiated | 2025-04-07 |
| Classified | 2025-05-02 |
| Reported by FDA | 2025-05-14 |
| Distributed | Nationwide (US) |
| Quantity | 30 vials |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 03760154000369 |
| Lot numbers | 240781 |
| Model numbers | P822692243 |
Product
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Reason for recall
Vials of implant bone granules may contain less product then specified on labeling.
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-1718-2025. 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.