Z-2092-2014Class II

Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior...

Name: Z-2092-2014 Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior...
Creator: Alphatec Spine, Inc.
Published: 2014-06-26
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2014-06-26 / Terminated

FDA source

Alphatec Spine, Inc. began a recall of 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... on 2014-06-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2092-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-26
Posted: 2014-07-22
Terminated: 2014-09-03
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).
Product code: NKB Thoracolumbosacral Pedicle Screw System
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 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 in commerce: 14 units total (12 units in US)
Distribution: Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.
Product codes and lots: Lot No. 7117902

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2092-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2092-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22

Product code NKB

K131119Class IISolanas Posterior Stabilization SystemAlphatec Spine, Inc. / cleared 2013-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)