Food, drugs, devices › Alphatec Spine, Inc.
Device recall: Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a
Alphatec Spine, Inc. (Carlsbad, CA) initiated this device recall on 26 Jun 2014; FDA lists 1 product record under event 68667, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 3 Sep 2014. Initiation: voluntary: firm initiated. Alphatec Spine, Inc. has 17 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Alphatec Spine, Inc., Carlsbad, CA.
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."
Distribution
"Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2092-2014 | 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). | 14 units total (12 units in US) | Class II | Terminated | 30 Jul 2014 |
Context
Other enforcement events for Alphatec Spine, Inc.
All 17 events for Alphatec Spine, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Sep 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.