[pending] Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purit
Pending LLM rewrite. Source: FDA_DEVICE Z-1718-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Vials of implant bone granules may contain less product then specified on labeling.
The recalled product
- Product
- Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
- Manufacturer
- SCIENCE & BIO MATERIALS
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 240781/UDI: 03760154000369
Distribution
Distributed nationwide across the United States.
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