Alphatec Spine, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2092-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: June 26, 2014

Date Posted: July 30, 2014

Recall Number: Z-2092-2014

Event ID: 68667

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.

Status: Terminated

Product Quantity: 14 units total (12 units in US)

Code Information:

Lot No. 7117902

Distribution Pattern:

Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.

Voluntary or Mandated:

Voluntary: Firm initiated