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
- Recall Number
- Z-0323-2024
- Event Number
- 93296
- Firm
- Musculoskeletal Transplant Foundation, Inc.
- FEI Number
- 3001236616
- Product Code
- MQV
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- September 22, 2023
- Posted
- November 17, 2023
- Address
- 125 May St, Ste 300, Edison, NJ, 08837-3264
Description
DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
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].
US Nationwide distribution in the states of PA, TX, WA.
18 units