Recall Z-2092-2014 ยท NKB Thoracolumbosacral Pedicle Screw System
Alphatec Spine, Inc.
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).
| Date | Jul 22, 2014 (initiated Jun 26, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | Alphatec Spine, Inc. sent an Urgent Medical Device Notification letter dated June 20, 2014, June 26, 2014, to all affected customers. Alphatec Spine received a report of the 10mm fixed depth drill from this lot which malfunctioned and golden stop slid from its fixed position during use. The letter informs the customers of the problems identifed and the actions to be taken. Customers are instructed to confirm that they received the notification letter by completing the customer response form. Completed forms are to be sent to Alphatec Spine at 5818 El Camino Rd, Carlsbad, CA 92008. Customer |
| Quantity | 14 units total (12 units in US) |
| Distribution | Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131119 | SOLANAS POSTERIOR STABILIZATION SYSTEM Alphatec Spine, Inc., May 21, 2013 |