FDA Device recall Z-2092-2014
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10 by Alphatec Spine, citing alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during u….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2092-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-26 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alphatec Spine |
| Distribution | US |
Product
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
Reason
Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use.
Identifiers
| code_info | Lot No. 7117902 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2092-2014%22
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