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U.S. Department of Health and Human Services

Class 2 Device Recall Solanas 2.1mm FIXED DEPTH DRILL, 10mm

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  Class 2 Device Recall Solanas 2.1mm FIXED DEPTH DRILL, 10mm see related information
Date Initiated by Firm June 26, 2014
Date Posted July 22, 2014
Recall Status1 Terminated 3 on September 03, 2014
Recall Number Z-2092-2014
Recall Event ID 68667
510(K)Number K131119  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
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).
Code Information Lot No. 7117902
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad CA 92008-8816
For Additional Information Contact
760-431-9286
Manufacturer 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 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = ALPHATEC SPINE, INC.
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