PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 14, 2025 Initiated: April 7, 2025 #Z-1718-2025

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.

Details

Recalling Firm
SCIENCE & BIO MATERIALS
Units Affected
30 vials
Distribution
US Nationwide distribution.
Location
Lourdes, N/A

Frequently Asked Questions

What product was recalled?
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity). Recalled by SCIENCE & BIO MATERIALS. Units affected: 30 vials.
Why was this product recalled?
Vials of implant bone granules may contain less product then specified on labeling.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 14, 2025. Severity: Moderate. Recall number: Z-1718-2025.