Solanas 2 — Class II medical device recall Z-2092-2014
Terminated recall by Alphatec Spine, Inc., reported 2014-07-30, distributed nationwide. Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrumen
| Recall number | Z-2092-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alphatec Spine, Inc., Carlsbad, CA, United States |
| Recall initiated | 2014-06-26 |
| Classified | 2014-07-22 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2014-09-03 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Lot numbers | 7117902 |
| Model numbers | 63928-10 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2092-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.