FDA Enforcement
Class II
Ongoing
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
Recall: Z-2131-2026
·
Reported May 13, 2026
Enforcement
- Recall Number
- Z-2131-2026
- Event ID
- 98733
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Orthorebirth Co Ltd
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- May 13, 2026
- Initiation Date
- March 25, 2026
- Classification Date
- May 7, 2026
- Address
- 3 Chome 17-43, Chigasakihigashi; Tsuzuki, Yokohama, N/A, Japan
Description
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.
Code Info
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
Distribution
US Nationwide distribution in the states of CA, FL.
Quantity
1266