Device product
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Z-2132-2026
Product summary
- Event
- Event 98733
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20
- Official record key
device-enforcement:Z-2132-2026
Official wording
Reason: Resorbable bone void filler falls outside standard specifications.
Code information: UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
Distribution pattern: US Nationwide distribution in the states of CA, FL.
Derived failure modes
-
Unknown
Resorbable bone void filler falls outside standard specifications.