Bio 1 Granules for Filling ¿ 1 mm recall: Labeling Error
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Why was Bio 1 Granules for Filling ¿ 1 mm recalled?
Vials of implant bone granules may contain less product then specified on labeling.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 240781/UDI: 03760154000369
- Product
- Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
- Recalling firm
- SCIENCE & BIO MATERIALS
- Quantity
- 30 vials
- Distribution
- US Nationwide distribution.
- Recall date
- May 14, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)