FDA DevicesClass II
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC,...
Published: May 13, 2026Recall ID: Z-2131-2026Category: devicesCountry: US
Reason for Recall / Hazard
Resorbable bone void filler falls outside standard specifications.
Product Description & Identification
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
Additional Source Details
| Field | Value |
|---|---|
| City | Yokohama |
| Event id | 98733 |
| Address 1 | 3 Chome 17-43 |
| Address 2 | Chigasakihigashi; Tsuzuki |
| Code info | UDI-DI: 04573190050552. Lots: 25043001, 25043002, 25043003, 25051401, 25051402, 25051701, 25051702, 25060701, 25060702, 25060703, 25060704, 25083001, 25083002, 25083003, 25083004, 25083005, 25120301, 25122701, 25122702, 26020401 25F07101AA, 25F07103AA, 25F07106AA, 25H27105AA, 25H27107AA, 25H27102AA, 25H27103AA, 25H27104AA, 25K08102AA, 25K08103AA, 25K08101AA, 25J27104AA, 25J27103AA, 25J27102AA, 25J27101AA, 25H27108AA, 25H27101AA |
| Postal code | N/A |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 1266 |
| 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.