United StatesOrthorebirth Co Ltd is recalling BioCera Fibers, Bioresorbable Bone Void Filler (REF ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC) and ZENBONE (REF ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z); affected UDI-DI codes are 04573190050552 and 04573190050637 and multiple lot numbers are listed. The products were recalled because the resorbable bone void filler falls outside standard specifications; units were distributed nationwide in the US, including California and Florida.
What's being recalled
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Recalling firm: Orthorebirth Co Ltd, Yokohama, Japan.
How to identify it
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 UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
The hazard
Resorbable bone void filler falls outside standard specifications.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of CA, FL.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)