Bio 1 Implant Bone Granules Recalled for Underfilled Vials

Agency Publication Date: May 2, 2025

Summary

SCIENCE & BIO MATERIALS is recalling 30 vials of Bio 1 Granules for Filling. These implantable bone granules, which are used in medical procedures, may contain less product than the 2 cm³ volume specified on the label. While no injuries have been reported, underfilled vials could result in surgeons having insufficient material during a procedure.

Risk

If a vial contains less material than expected, a surgical procedure may be delayed or compromised if additional bone granules are not immediately available to complete the filling.

What You Should Do

This recall involves Bio 1 Granules for Filling ≤ 1 mm (2 cm³) sold under the BIOSORB brand with reference number P822692243 and Lot number 240781.
Identify affected vials by checking for Lot number 240781 or UDI 03760154000369 on the product packaging.
Stop using the recalled product immediately.
Contact SCIENCE & BIO MATERIALS or your authorized medical distributor to arrange for the return, replacement, or correction of the affected product.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

Other Action

Manufacturer initiated correction/return due to underfilled vials.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Bio 1 Granules for Filling ≤ 1 mm (2 cm³)

Variants: BIOSORB (BTCP 95% minimum purity)

Model / REF:

P822692243

Lot Numbers:

240781

UDI:

03760154000369

Recall #: Z-1718-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96632

Status: Active

Manufacturer: SCIENCE & BIO MATERIALS

Sold By: Authorized medical distributors

Manufactured In: France

Units Affected: 30 vials

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves Bio 1 Granules for Filling ≤ 1 mm (2 cm³) sold under the BIOSORB brand with reference number P822692243 and Lot number 240781.

Identify affected vials by checking for Lot number 240781 or UDI 03760154000369 on the product packaging.

Stop using the recalled product immediately.

Contact SCIENCE & BIO MATERIALS or your authorized medical distributor to arrange for the return, replacement, or correction of the affected product.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.