Z-1718-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2025
- Initiation Date
- April 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 vials
Product Description
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Reason for Recall
Vials of implant bone granules may contain less product then specified on labeling.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot # 240781/UDI: 03760154000369