FDA-Device2014-07-30Class II
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).
Alphatec Spine, Inc.
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.
Sold states
Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.
Affected count
14 units total (12 units in US)
Manufactured in
5818 El Camino Real, Carlsbad, CA, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2092-2014Don't want to check this manually?
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