Z-2132-2026 Class II Ongoing
FDA device recall Z-2132-2026 was initiated by Orthorebirth Co Ltd on March 25, 2026 and is designated Class II. Reason for recall: Resorbable bone void filler falls outside standard specifications. The recall status is ongoing. Affected quantity: 20.
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