FDA recall Z-1718-2025

SCIENCE & BIO MATERIALS · Class II · device

Product

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

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-04-07
Report date
2025-05-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lourdes, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1718-2025