FDA recall, , Moderate risk
BioCera Fibers and ZENBONE
BioCera Fibers bone void filler falls outside standard specifications.
Summary by Recall Canary from the FDA notice
What happened
Orthorebirth Co Ltd, of Yokohama, Japan, recalled Zenbone and BioCera Fibers bone void filler products because the resorbable bone void filler falls outside standard specifications. The FDA added the recall to its Enforcement Report on May 7, 2026. The products were distributed nationwide in the states of California and Florida.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
- UDI-DI
- 04573190050552
- 25043001
- 25043002
- 25043003
- 25051401
- 25051402
- 25051701
- 25051702
- 25060701
- 25060702
- 25060703
- 25060704
- 25083001
- 25083002
- 25083003
- 25083004
- 25083005
- 25120301
- 25122701
- 25122702
- 26020401
- Lot code
- 25F07101AA
- 25F07103AA
- 25F07106AA
- 25H27105AA
- 25H27107AA
- 25H27102AA
- 25H27103AA
- 25H27104AA
- 25K08102AA
- 25K08103AA
- 25K08101AA
- 25J27104AA
- 25J27103AA
- 25J27102AA
- 25J27101AA
- 25H27108AA
- 25H27101AA
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
- UDI-DI
- 04573190050637
- Lot code
- 25F07104JF
- 25F07105JF
- 25F07106JF
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Florida.
- Company
- Orthorebirth Co LtdYokohama, Japan
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98733
- Recall numbers
- Z-2131-2026 to Z-2132-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
