FDA recall Z-1897-2026

XTANT Medical Holdings, Inc · Class II · device

Product

nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc

Reason for recall

Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

Distribution

US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.

Key facts

Status: Ongoing
Initiation date: 2026-03-09
Report date: 2026-04-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Belgrade, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1897-2026