FDA Medical Device Recalls (openFDA)
SCIENCE & BIO MATERIALS: Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
- Recall number
- Z-1718-2025
- Recalling firm
- SCIENCE & BIO MATERIALS
- Product
- Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
- Status
- Open, Classified
- Initiated
- 2025-04-07
- Posted
- 2025-05-02
- Terminated
- not on file
- Reason
- Vials of implant bone granules may contain less product then specified on labeling.
- 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 regine.estaun@sbm-fr.com within 7 days of the date of receipt. .
- Quantity
- 30 vials
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot # 240781/UDI: 03760154000369
- 510(k) numbers
- ["K021963"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3004051158
- Firm city
- Lourdes
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28