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Recall Observatory FDA recall evidence

Device 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).

Z-2092-2014

June 26, 2014

Class II

Product summary

Firm
Alphatec Spine, Inc.
Event
Event 68667
Status
Terminated
Classification
Class II
Quantity
14 units total (12 units in US)
Official record key
device-enforcement:Z-2092-2014

Official wording

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.

Code information: Lot No. 7117902

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.