Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
This recall is currently active, issued May 2, 2025. It was issued by Science & Bio Materials Zi Du Monge Lourdes France.
- Recall Initiated
- April 7, 2025
- Posted
- May 2, 2025
- Recall Number
- Z-1718-2025
- Quantity
- 30 vials
- Official Source
- View on FDA website ↗
Reason for Recall
Vials of implant bone granules may contain less product then specified on labeling.
Distribution
US Nationwide distribution.
Lot / Code Info
Lot # 240781/UDI: 03760154000369
Root Cause
Process control
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. .