Yokohama, Japan
Orthorebirth Co Ltd recalls
1 recall recorded since 2018, most recently on 25 March 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 March 2026
- Reason
- Resorbable bone void filler falls outside standard specifications.
- Distribution
- US Nationwide distribution in the states of CA, FL.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2132-2026, Z-2131-2026
- ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
- BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.