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

FDA Recall #Z-1718-2025 — Class II — April 7, 2025

Recall #Z-1718-2025 Date: April 7, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

SCIENCE & BIO MATERIALS — Lourdes, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

30 vials

Distribution

US Nationwide distribution.

Code Information

Lot # 240781/UDI: 03760154000369

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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