Device product
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
Z-2131-2026
Product summary
- Event
- Event 98733
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1266
- Official record key
device-enforcement:Z-2131-2026
Official wording
Reason: Resorbable bone void filler falls outside standard specifications.
Code information: 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 pattern: US Nationwide distribution in the states of CA, FL.
Derived failure modes
-
Unknown
Resorbable bone void filler falls outside standard specifications.