CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
Zenbone, REF: Orb-0320C-Z, Orb-0310C-Z, Orb-0304C recalled
Orthorebirth is recalling Zenbone, REF: Orb-0320C-Z, Orb-0310C-Z, Orb-0304C-Z, 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-2132-2026
- FDA event ID
- 98733
- Recalling firm
- Orthorebirth, 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
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Where it was distributed
US Nationwide distribution in the states of CA, FL.
Questions about this recall
Why was it recalled?
Resorbable bone void filler falls outside standard specifications.
Which lots are affected?
UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98733| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | BioCera Fibers, Bioresorbable Bone Void Filler recalled | Orthorebirth | Other | Nationwide |
More recalls from Orthorebirth
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BioCera Fibers, Bioresorbable Bone Void Filler recalled | Orthorebirth | Other | Nationwide |
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