Bio 1 Bone Granules Recalled for Potentially Underfilled Vials
SCIENCE & BIO MATERIALS is recalling Bio 1 Granules for Filling due to vials that may contain less product than stated on labeling. The recall affects 30 vials distributed nationwide.
What this means for you
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 for a labeling discrepancy where vials may contain less product than labeled. No incidents, injuries, or illnesses have been reported, and the hazard is a quantity/accuracy issue rather than a safety threat.
Plain-English summary
Bio 1 Granules for Filling (lot 240781, REF: P822692243) is a bone implant granule material manufactured by SCIENCE & BIO MATERIALS. The product has been recalled because vials may contain less product than specified on their labels.
The recall affects 30 vials that were distributed nationwide in the United States.
Healthcare providers and facilities should verify whether they have the recalled lot number. Affected vials should not be used pending further guidance from the manufacturer or regulatory authorities.
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
- Hazard
- underfill
- labeling-error
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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