FDA recall Z-0323-2024

Musculoskeletal Transplant Foundation, Inc. · Class II · 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

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

US Nationwide distribution in the states of PA, TX, WA.

Key facts

Status
Ongoing
Initiation date
2023-09-22
Report date
2023-11-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Edison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0323-2024