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Orthorebirth Co Ltd: ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

Medical DevicesSource: FDA (device) · Date: 2026-05-13

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Orthorebirth Co Ltd
Product
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Reason / hazard
Resorbable bone void filler falls outside standard specifications.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CA, FL.
Recall initiated
2026-03-25
Code info
UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
Product quantity
20
Voluntary mandated
Voluntary: Firm initiated
City
Yokohama
Country
Japan
Event id
98733
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