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U.S. Department of Health and Human Services

Class 2 Device Recall DBX Demineralized Bone Matrix Putty

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  Class 2 Device Recall DBX Demineralized Bone Matrix Putty see related information
Date Initiated by Firm September 22, 2023
Date Posted November 17, 2023
Recall Status1 Open3, Classified
Recall Number Z-0323-2024
Recall Event ID 93296
510(K)Number K040262  
Product Classification Filler, bone void, calcium compound - Product Code MQV
Product DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
Model Number: 038100
Code Information GUID: W4184038100T0473 Serial #s: 002220854711400006 002220854711400056 002220854711400003 002220854711400008 002220854711400009 002220854711400001 002220854711400002 002220854711400010 002220854711400011 002220854711400012 002220854711400013 002220854711400014 002220854711400004 002220854711400005 002220854711400007 Exp.Date: June 20, 2025
Recalling Firm/
Manufacturer
Musculoskeletal Transplant Foundation, Inc.
125 May St Ste 300
Edison NJ 08837-3264
For Additional Information Contact SAME
732-661-2209
Manufacturer Reason
for Recall
Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
FDA Determined
Cause 2
Labeling Change Control
Action MTF Biologicals issued Voluntary Market Withdrawal Notification Letter via customer service scripts on 9/22/23 and provided written notification via letter and/or Email on 10/3/23 to customers . Letter states reason for recall, health risk and action to take: If the tissue is still available in your inventory, we request you return the tissue to us. We will send a replacement if required. Should you have any questions, please contact Customer Service at 1-800-433-6576, or please feel free to contact me at 732-661-2209, or email MTF Regulatory Affairs at Regulatory_Customer_Inquiry@mtf.org.
Quantity in Commerce 18 units
Distribution US Nationwide distribution in the states of PA, TX, WA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MQV and Original Applicant = MUSCULOSKELETAL TRANSPLANT FOUNDATION
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