FDAFDA · Food and drugs·Recall number Z-2131-2026
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
Published May 13, 2026 · Recall initiated: March 25, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Resorbable bone void filler falls outside standard specifications.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Orthorebirth Co Ltd
- Distributor
- US Nationwide distribution in the states of CA, FL.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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