FDAHealthMarch 25, 2026
Orthorebirth Co Ltd — ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
⚠️ Resorbable bone void filler falls outside standard specifications.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 25, 2026
US Nationwide distribution in the states of CA, FL.
What's affected?
- Product
- ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
- Brand
- Orthorebirth Co Ltd
- Lot code
- 25F07104JF
Additional details
UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 20.
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