Device 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
Z-0323-2024
Product summary
- Event
- Event 93296
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-0323-2024
Official wording
Reason: Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
Code information: GUID: W4184038100T0473 Serial #s: 002220854711400006 002220854711400056 002220854711400003 002220854711400008 002220854711400009 002220854711400001 002220854711400002 002220854711400010 002220854711400011 002220854711400012 002220854711400013 002220854711400014 002220854711400004 002220854711400005 002220854711400007 Exp.Date: June 20, 2025
Distribution pattern: US Nationwide distribution in the states of PA, TX, WA.
Derived failure modes
-
Unknown
Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.