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Open, Classified

DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100

FDA Recall Z-0323-2024 · Posted 2023-11-17

Recalling FirmMusculoskeletal Transplant Foundation, Inc.
Recall StatusOpen, Classified
Product CodeMQV
Date Initiated2023-09-22
Product Quantity18 units

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.

Firm 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].

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide distribution in the states of PA, TX, WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040262DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIXMusculoskeletal Transplant Foundation · 2005-03-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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