BioCera Fibers — Class II medical device recall Z-2131-2026
Ongoing recall by Orthorebirth Co Ltd, reported 2026-05-13, distributed nationwide. Resorbable bone void filler falls outside standard specifications.
| Recall number | Z-2131-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthorebirth Co Ltd, Yokohama, Japan |
| Recall initiated | 2026-03-25 |
| Classified | 2026-05-07 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 1,266 |
| UPC / GTIN / UDI-DI | 04573190050552 |
| Lot numbers | 25043001, 25043002, 25043003, 25051401, 25051402, 25051701, 25051702, 25060701, 25060702, 25060703, 25060704, 25083001, 25083002, 25083003, 25083004, 25083005, 25120301, 25122701, 25122702, 25F07101AA, 25F07103AA, 25F07106AA, 25H27101AA, 25H27102AA, 25H27103AA, 25H27104AA, 25H27105AA, 25H27107AA, 25H27108AA, 25J27101AA, 25J27102AA, 25J27103AA, 25J27104AA, 25K08101AA, 25K08102AA, 25K08103AA, 26020401 |
| Model numbers | ORB-0302C-KC, ORB-0304C-KC, ORB-0305D-KC, ORB-0310C-KC, ORB-0320C-KC |
Product
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
Reason for recall
Resorbable bone void filler falls outside standard specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2131-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.