Device product
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Z-1718-2025
Product summary
- Event
- Event 96632
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 vials
- Official record key
device-enforcement:Z-1718-2025
Official wording
Reason: Vials of implant bone granules may contain less product then specified on labeling.
Code information: Lot # 240781/UDI: 03760154000369
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Vials of implant bone granules may contain less product then specified on labeling.