FDA Recall
Open, Classified
Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Recall: Z-1718-2025
·
Initiated April 7, 2025
Recall
- Recall Number
- Z-1718-2025
- Event Number
- 96632
- Firm
- SCIENCE & BIO MATERIALS Zi Du Monge Lourdes France
- FEI Number
- 3004051158
- Product Code
- MQV
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- April 7, 2025
- Posted
- May 2, 2025
Description
Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Reason
Vials of implant bone granules may contain less product then specified on labeling.
Action
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 [email protected] within 7 days of the date of receipt. .
Distribution
US Nationwide distribution.
Quantity
30 vials