FDA Device recall Z-2132-2026
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
- FDA Device
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z by Orthorebirth, citing resorbable bone void filler falls outside standard specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2132-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-25 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Orthorebirth |
| Distribution | US |
Product
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Reason
Resorbable bone void filler falls outside standard specifications.
Identifiers
| code_info | UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2132-2026%22
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