ZENBONE recall (Orthorebirth Co Ltd)
Medical deviceClass IIOngoing
Summary: Orthorebirth Co Ltd is recalling ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z. Reason: Resorbable bone void filler falls outside standard specifications.
What is being recalled
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Why
Resorbable bone void filler falls outside standard specifications.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of CA, FL. (states named: California, Florida)
How to tell if yours is affected
UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2132-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 25, 2026 |
| Reported | May 13, 2026 |
| Company | Orthorebirth Co Ltd |
| Company location | Yokohama, Japan |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 20 |
More recalls from Orthorebirth Co Ltd · all medical device recalls · recalls from March 2026