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

FDA device recall Z-2092-2014 · posted 2014-07-22 · Terminated

Recall details

Recalling firm

Alphatec Spine, Inc.

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.

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.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

NKB

Quantity affected

14 units total (12 units in US)

Distribution

Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.

Date initiated

2014-06-26

Date posted

2014-07-22

Date terminated

2014-09-03

Location

Carlsbad, CA

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