Bio 1 Granules for Filling implant bone graft material nationwide recall
Bio 1 Granules for Filling implant bone granules may contain less product than specified on the label. The affected lot is 240781 (UDI: 03760154000369), distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling discrepancy (actual quantity less than labeled). The source text does not report any illnesses, injuries, or hospitalizations. The hazard is quantity underfill rather than contamination or structural failure.
Plain-English summary
SCIENCE & BIO MATERIALS is recalling Bio 1 Granules for Filling (REF: P822692243, Material: BIOSORB with 95% minimum purity) because vials may contain less product than specified on the labeling. The recalled product consists of 30 vials with lot number 240781 and UDI 03760154000369, distributed nationwide in the United States.
Patients or healthcare providers who have this product should contact their physician or healthcare provider for guidance. The FDA has classified this as a Class II recall.
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
- Affected units
- 30
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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