FDA recall Z-2131-2026

Orthorebirth Co Ltd · Class II · device

Product

BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC

Reason for recall

Resorbable bone void filler falls outside standard specifications.

Distribution

US Nationwide distribution in the states of CA, FL.

Key facts

Status
Ongoing
Initiation date
2026-03-25
Report date
2026-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Yokohama, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2131-2026