FDA Medical devices recall ·
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿) recall
- Recall number
- Z-1718-2025
- Date
- (initiated April 7, 2025)
- Company / brand
- Science & Bio Materials
Zi Du Monge, Lourdes, N/A, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 30 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Why was it recalled?
Vials of implant bone granules may contain less product then specified on labeling.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 240781/UDI: 03760154000369
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1718-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.