FDA Device recall Z-1769-2021
VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10
- FDA Device
- Class II
- terminated
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class II recall of VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10 by Zavation, citing products distributed as sterile may not have been adequately sterilized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1769-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-25 |
| Published | 2021-06-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Zavation |
| Distribution | US |
Product
VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
Reason
Products distributed as sterile may not have been adequately sterilized
Identifiers
| code_info | Lot Numbers: 10085ZV, 10086ZV, 11205ZV, 11217ZV, 11554ZV, 11558ZV, 11559ZV |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1769-2021%22
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