FDA recall Z-2132-2026
Orthorebirth Co Ltd · Class II · device
Product
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
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-2132-2026