Recall Z-1718-2025— SCIENCE & BIO MATERIALS

Name: FDA recall Z-1718-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-07

Class II · Ongoing

Class II FDA medical device recall by SCIENCE & BIO MATERIALS, initiated 2025-04-07. It names one FDA 510(k) clearance: K021963. Product: Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity). Reason: Vials of implant bone granules may contain less product then specified on labeling..

Recalling firm: SCIENCE & BIO MATERIALS
Classification: Class II
Status: Ongoing
Initiated: 2025-04-07
Firm location: Lourdes, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K021963 — BIOSORB RESORBABLE VOID FILLERSciences ET Bio Materiaux (Sbm)·cleared 2003-01-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.