Recall Z-2092-2014— Alphatec Spine, Inc.

Name: FDA recall Z-2092-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-26

Class II · Terminated

Class II FDA medical device recall by Alphatec Spine, Inc., initiated 2014-06-26, terminated 2014-09-03. It names one FDA 510(k) clearance: K131119. 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: 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..

Recalling firm: Alphatec Spine, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-26
Terminated: 2014-09-03
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131119 — SOLANAS POSTERIOR STABILIZATION SYSTEMAlphatec Spine, Inc.·cleared 2013-05-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.