FDAFDA · Food and drugs·Recall number Z-2092-2014
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).
Published July 30, 2014 · Recall initiated: June 26, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alphatec Spine, Inc.
- Distributor
- Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.
- Lot
- Lot No. 7117902
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.