Recalling firm
Orthorebirth Co Ltd
Product type
Device
Status
Ongoing
Report date
2026-05-13
Distribution
US Nationwide distribution in the states of CA, FL.
Product quantity
20
Initiated by
Voluntary: Firm initiated
Reason for recall
Resorbable bone void filler falls outside standard specifications.
Product description
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Code / lot info
UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.