Orthorebirth Co Ltd recalls BioCera Fibers
- Recalling company
- Orthorebirth Co Ltd
- Product
- BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
- Reason
- Resorbable bone void filler falls outside standard specifications.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 25, 2026
- Reported
- May 13, 2026
- Distribution
- US Nationwide distribution in the states of CA, FL.
- Status
- Ongoing
- Quantity
- 1266
- Lot / codes
- 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
- Company location
- Yokohama
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2131-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2131-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.