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U.S. Department of Health and Human Services

Class 2 Device Recall BIO 1 Granules for filling 1mm (2cm3)

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 Class 2 Device Recall BIO 1 Granules for filling 1mm (2cm3)see related information
Date Initiated by FirmApril 07, 2025
Date PostedMay 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1718-2025
Recall Event ID 96632
510(K)NumberK021963 
Product Classification Filler, bone void, calcium compound - Product Code MQV
ProductBio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Code Information Lot # 240781/UDI: 03760154000369
FEI Number 3004051158
Recalling Firm/
Manufacturer		 SCIENCE & BIO MATERIALS
Zi Du Monge
Lourdes France
For Additional Information Contact Olivier LACAU
+33 05624221 01
Manufacturer Reason
for Recall		Vials of implant bone granules may contain less product then specified on labeling.
FDA Determined
Cause 2		Process control
ActionOn 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 in Commerce30 vials
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MQV
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