FDA Enforcement
Class II
Ongoing
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Recall: Z-2132-2026
·
Reported May 13, 2026
Enforcement
- Recall Number
- Z-2132-2026
- Event ID
- 98733
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Orthorebirth Co Ltd
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- May 13, 2026
- Initiation Date
- March 25, 2026
- Classification Date
- May 7, 2026
- Address
- 3 Chome 17-43, Chigasakihigashi; Tsuzuki, Yokohama, N/A, Japan
Description
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Reason
Resorbable bone void filler falls outside standard specifications.
Code Info
UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
Distribution
US Nationwide distribution in the states of CA, FL.
Quantity
20