Z-1718-2025Class II

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

Name: Z-1718-2025 Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Creator: Science & Bio Materials
Published: 2025-04-07
License: https://open.fda.gov/license/

Science & Bio Materials, S.B.M. SAS / initiated 2025-04-07 / Open, Classified / root cause: manufacturing process

FDA source

SCIENCE & BIO MATERIALS began a recall of Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity) on 2025-04-07. FDA classified it as Class II and gives the reason as "Vials of implant bone granules may contain less product then specified on labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1718-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-07
Posted: 2025-05-02
Recalling firm: Science & Bio Materials, S.B.M. SAS
Product: Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Vials of implant bone granules may contain less product then specified on labeling.
Root cause tag: manufacturing process
FDA root cause: Process control
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. .
Quantity in commerce: 30 vials
Distribution: US Nationwide distribution.
Product codes and lots: Lot # 240781/UDI: 03760154000369

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1718-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1718-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-02

Product code MQV

K021963Class IIBiosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) / cleared 2003-01-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)