Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243… recallZ-1718-2025 · Science & Bio Materials · initiated Apr 7, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Science & Bio Materials or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Vials of implant bone granules may contain less product then specified on labeling.
FDA root cause category: Process control
What the company is doing
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. .
Recall details
- Recall number
- Z-1718-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 7, 2025
- Posted by the FDA
- May 2, 2025
- Recalling firm
- Science & Bio Materials
- Quantity
- 30 vials
- Product code
- MQV
- FDA submissions
- K021963
- Distribution
- US Nationwide distribution.
Product description
Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Code information (models, lots, serial numbers)
Lot # 240781/UDI: 03760154000369
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BIOSORB BIO1 GranulesS.B.M · Filler, Bone Void, Calcium Compound1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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