Z-0323-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- September 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Product 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
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.
Distribution Pattern
US Nationwide distribution in the states of PA, TX, WA.
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