Reported May 13, 2026 · Ongoing
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC,…
Orthorebirth Co. Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthorebirth Co Ltd · 3 Chome 17-43 · Yokohama · N/A
Is this the product you have?
- BioCera Fibers, Bioresorbable Bone Void Filler
- REF
ORB-0320C-KCORB-0310C-KCORB-0304C-KCORB-0302C-KCORB-0305D-KC
- Lot codes and dates
- UDI-DI04573190050552
- Lots
2504300125043002250430032505140125051402250517012505170225060701250607022506070325060704250830012508300225083003250830042508300525120301251227012512270226020401 25F07101AA25F07103AA25F07106AA25H27105AA25H27107AA25H27102AA25H27103AA25H27104AA25K08102AA25K08103AA25K08101AA25J27104AA25J27103AA25J27102AA25J27101AA25H27108AA25H27101AA
- Amount recalled
- 1266
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Resorbable bone void filler falls outside standard specifications.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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