BioCera Fibers Bone Void Filler
Orthorebirth recalls BioCera Fibers bone void filler (REFs ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC) for out-of-spec.
Check the REF number on your product packaging against the recalled list. If your product is affected, stop using it and contact Orthorebirth Co Ltd for instructions on return and replacement.
Why it was recalled
Orthorebirth Co Ltd is recalling BioCera Fibers, a bioresorbable bone void filler, because it falls outside standard specifications. The affected REFs are ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, and ORB-0305D-KC.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z | 25F07104JF, 25F07105JF, 25F07106JF | Z-2132-2026 | 04573190050637 |
| BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC | 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 | Z-2131-2026 | 04573190050552, 25043001, 25043002, 25043003, 25051401, 25051402, 25051701, 25051702, 25060701, 25060702, 25060703, 25060704, 25083001, 25083002, 25083003, 25083004, 25083005, 25120301, 25122701, 25122702 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification