Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Summary
The FDA issued a Class II for Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BT by SCIENCE & BIO MATERIALS. Reason: Vials of implant bone granules may contain less product then specified on labeling..
Details
Source
Device Recall
External ID
Z-1718-2025
Action Date
2025-05-14
Status
Ongoing
Category
device
Product Description
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Lot/Code Info: Lot # 240781/UDI: 03760154000369
Quantity Affected: 30 vials
Reason for Recall
Vials of implant bone granules may contain less product then specified on labeling.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-07
Company
Lourdes, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 146 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SCIENCE & BIO MATERIALS has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SCIENCE & BIO MATERIALS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SCIENCE & BIO MATERIALS have FDA actions?
SCIENCE & BIO MATERIALS has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1718-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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