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Open, Classified

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

FDA Recall Z-1718-2025 · Posted 2025-05-02

Recalling FirmSCIENCE & BIO MATERIALS
Recall StatusOpen, Classified
Product CodeMQV
Date Initiated2025-04-07
Product Quantity30 vials

Reason for Recall

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

Firm Action

On April 7, 2025 Science for Biomaterials issued a "Urgent Medical Device Recall" Notification via E-Mail. 1. Verify the presence of Lot 240781 in stock and its distribution, if applicable. 2. Destroy the product after taking photos of the vials contents for exchange. Send us a certificate of destruction. or return to DMs to us for exchange 3. Acknowledge receipt of this batch recall by returning the Response Form to [email protected] within 7 days of the date of receipt. .

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021963BIOSORB RESORBABLE VOID FILLERSciences ET Bio Materiaux (Sbm) · 2003-01-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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