DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defect
FDA device recall Z-0323-2024 · posted 2023-11-17 · Open, Classified
Recall details
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- 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.
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- MQV
- Quantity affected
- 18 units
- Distribution
- US Nationwide distribution in the states of PA, TX, WA.
- Date initiated
- 2023-09-22
- Date posted
- 2023-11-17
- Location
- Edison, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX (K040262) | Musculoskeletal Transplant Foundation | 2005-03-17 |