FDA Device recall Z-2572-2026
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1
- FDA Device
- Class II
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1 by Surgify Medical Oy, citing potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2572-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-30 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Surgify Medical Oy |
| Distribution | US |
Product
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
Reason
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Identifiers
| code_info | UDI: 06429811532137 ; All lots until the IFU update has been implemented |
|---|
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-2572-2026%22
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