DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
This recall is currently active, issued November 17, 2023. It was issued by Musculoskeletal Transplant Foundation, Inc..
- Recall Initiated
- September 22, 2023
- Posted
- November 17, 2023
- Recall Number
- Z-0323-2024
- Quantity
- 18 units
- Firm Location
- Edison, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of PA, TX, WA.
Lot / Code Info
GUID: W4184038100T0473 Serial #s: 002220854711400006 002220854711400056 002220854711400003 002220854711400008 002220854711400009 002220854711400001 002220854711400002 002220854711400010 002220854711400011 002220854711400012 002220854711400013 002220854711400014 002220854711400004 002220854711400005 002220854711400007 Exp.Date: June 20, 2025
Root Cause
Labeling Change Control
Action Taken
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.