CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
BioCera Fibers, Bioresorbable Bone Void Filler recalled
Orthorebirth Co is recalling BioCera Fibers, Bioresorbable Bone Void Filler, distributed nationwide in the US. The recall was initiated on 25 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2131-2026
- FDA event ID
- 98733
- Recalling firm
- Orthorebirth Co, Yokohama
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Mar 2026
- FDA classified
- 7 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Mar 2026 | Recall initiated by company | |
| 7 May 2026 | Classified by FDA | +43 days |
| 13 May 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Resorbable bone void filler falls outside standard specifications.
Product as listed by the FDA
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
Where it was distributed
US Nationwide distribution in the states of CA, FL.
Questions about this recall
Is BioCera Fibers, Bioresorbable Bone Void Filler recalled?
Yes. Orthorebirth Co recalled BioCera Fibers, Bioresorbable Bone Void Filler on 25 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-2131-2026.
Why was it recalled?
Resorbable bone void filler falls outside standard specifications.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the states of CA, FL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Orthorebirth Co
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Zenbone, REF: Orb-0320C-Z, Orb-0310C-Z, Orb-0304C-Z recalled | Orthorebirth Co | Other | Nationwide |
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