FDA Enforcement
Class II
Ongoing
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: Z-0323-2024
·
Reported November 29, 2023
Enforcement
- Recall Number
- Z-0323-2024
- Event ID
- 93296
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Musculoskeletal Transplant Foundation, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- November 29, 2023
- Initiation Date
- September 22, 2023
- Classification Date
- November 17, 2023
- Address
- 125 May St Ste 300, N/A, Edison, NJ, 08837-3264, United States
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
Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
Code Info
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
US Nationwide distribution in the states of PA, TX, WA.
Quantity
18 units