Recall Z-2092-2014
Alphatec Spine, Inc. · initiated June 26, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: Lot No. 7117902
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.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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. Customers may also return forms by fax at (760) 431-0289. Customers with questions were instructed to contact Alphatec Spine's Customer Service Department on how to return the affected product. For questions regarding this recall call 760-431-9286.
Details
- Recall number
- Z-2092-2014
- Initiated
- June 26, 2014
- Posted by FDA
- July 22, 2014
- Terminated
- September 3, 2014
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 14 units total (12 units in US)
- Distribution
- Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.
- Recalling firm
- Alphatec Spine, Inc., Carlsbad, CA