Recall Z-0323-2024 ยท MQV Filler, Bone Void, Calcium Compound
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
| Date | Nov 17, 2023 (initiated Sep 22, 2023) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040262 | DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX Musculoskeletal Transplant Foundation, Mar 17, 2005 |