Alphatec Spine, Inc. recalls Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System,

Recalled July 30, 2014 · FDA recall Z-2092-2014 · Alphatec Spine

Hazard

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. · FDA Class II

Units

14 units total (12 units in US)

Sold at

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

Description

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.

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).

Manufacturer(s)

Alphatec Spine, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →