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 Insight

This FDA Devices action (record #Z-2092-2014) was formally reported on July 30, 2014, with the manufacturer initiating the action on June 26, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Alphatec Spine, Inc. is listed as the recalling firm, operating out of Carlsbad, CA. Federal records indicate 14 units total (12 units in US) units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.