FDA DevicesClass II
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Published: May 13, 2026Recall ID: Z-2132-2026Category: devicesCountry: US
Reason for Recall / Hazard
Resorbable bone void filler falls outside standard specifications.
Product Description & Identification
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Additional Source Details
| Field | Value |
|---|---|
| City | Yokohama |
| Event id | 98733 |
| Address 1 | 3 Chome 17-43 |
| Address 2 | Chigasakihigashi; Tsuzuki |
| Code info | UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF |
| Postal code | N/A |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 20 |
| Reason for recall | Resorbable bone void filler falls outside standard specifications. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260325 |
| Center classification date | 20260507 |
Overview
- Recalling FirmOrthorebirth Co Ltd
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of CA, FL.