Z-2132-2026 Class II Ongoing

Recalled by Orthorebirth Co Ltd — Yokohama

Recall Details

Product Type
Devices
Report Date
May 13, 2026
Initiation Date
March 25, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20

Product Description

ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

Reason for Recall

Resorbable bone void filler falls outside standard specifications.

Distribution Pattern

US Nationwide distribution in the states of CA, FL.

Code Information

UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF