Z-0323-2024Class II

DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or...

Name: Z-0323-2024 DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or...
Creator: Musculoskeletal Transplant Foundation, Inc.
Published: 2023-09-22
License: https://open.fda.gov/license/

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics / initiated 2023-09-22 / Open, Classified / root cause: labeling and UDI

FDA source

Musculoskeletal Transplant Foundation, Inc. began a recall of DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model... on 2023-09-22. FDA classified it as Class II and gives the reason as "Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0323-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-22
Posted: 2023-11-17
Recalling firm: Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics
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
Product code: MQV Filler, Bone Void, Calcium Compound
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.
Root cause tag: labeling and UDI
FDA 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 [email protected].
Quantity in commerce: 18 units
Distribution: US Nationwide distribution in the states of PA, TX, WA.
Product codes and lots: GUID: W4184038100T0473 Serial #s: 002220854711400006 002220854711400056 002220854711400003 002220854711400008 002220854711400009 002220854711400001 002220854711400002 002220854711400010 002220854711400011 002220854711400012 002220854711400013 002220854711400014 002220854711400004 002220854711400005 002220854711400007 Exp.Date: June 20, 2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0323-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0323-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-17

Product code MQV

K040262Class IIDbx Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix MixMusculoskeletal Transplant Foundation / cleared 2005-03-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)