Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
FDA device recall Z-1718-2025 · posted 2025-05-02 · Open, Classified
Recall details
- Recalling firm
- SCIENCE & BIO MATERIALS
- Reason for recall
- Vials of implant bone granules may contain less product then specified on labeling.
- Action taken
- On April 7, 2025 Science for Biomaterials issued a "Urgent Medical Device Recall" Notification via E-Mail. 1. Verify the presence of Lot 240781 in stock and its distribution, if applicable. 2. Destroy the product after taking photos of the vials contents for exchange. Send us a certificate of destruction. or return to DMs to us for exchange 3. Acknowledge receipt of this batch recall by returning the Response Form to regine.estaun@sbm-fr.com within 7 days of the date of receipt. .
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- MQV
- Quantity affected
- 30 vials
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-04-07
- Date posted
- 2025-05-02
- Location
- Lourdes, France
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOSORB RESORBABLE VOID FILLER (K021963) | Sciences ET Bio Materiaux (Sbm) | 2003-01-28 |