Class II

Medical Device Recall: Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

SCIENCE & BIO MATERIALS · April 7, 2025

Reason for Recall

Vials of implant bone granules may contain less product then specified on labeling.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

30 vials

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1718-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.