FDA Medical Device Recalls (openFDA)
Musculoskeletal Transplant Foundation, Inc.: DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
- Recall number
- Z-0323-2024
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2023-09-22
- Posted
- 2023-11-17
- Terminated
- not on file
- Reason
- Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
- Root cause
- 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
- 18 units
- Distribution
- US Nationwide distribution in the states of PA, TX, WA.
- Lot, serial or model codes
- GUID: W4184038100T0473 Serial #s: 002220854711400006 002220854711400056 002220854711400003 002220854711400008 002220854711400009 002220854711400001 002220854711400002 002220854711400010 002220854711400011 002220854711400012 002220854711400013 002220854711400014 002220854711400004 002220854711400005 002220854711400007 Exp.Date: June 20, 2025
- 510(k) numbers
- ["K040262"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3001236616
- Firm city
- Edison
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28