FDA Medical Device Recalls (openFDA)
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).
- Recall number
- Z-2092-2014
- Recalling firm
- Alphatec Spine, Inc.
- 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).
- Status
- Terminated
- Initiated
- 2014-06-26
- Posted
- 2014-07-22
- Terminated
- 2014-09-03
- 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. 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.
- Quantity
- 14 units total (12 units in US)
- Distribution
- Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.
- Lot, serial or model codes
- Lot No. 7117902
- 510(k) numbers
- ["K131119"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 2027467
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28