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U.S. Department of Health and Human Services

Class 2 Device Recall Leucadia Autolok" Polyaxial Pedicle Screw System

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  Class 2 Device Recall Leucadia Autolok" Polyaxial Pedicle Screw System see related information
Date Initiated by Firm May 06, 2013
Date Posted May 28, 2013
Recall Status1 Terminated 3 on September 25, 2014
Recall Number Z-1421-2013
Recall Event ID 65165
510(K)Number K113366  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Leucadia Autolok" Polyaxial Pedicle Screw System.

Intended to help provide correction, immobilization and stabilization of spinal segments.
Code Information 83010 85001 85002 83005-30  83005-35  83005-40  83005-45  83005-50  83006-30  83006-35  83006-40  83006-45  83006-50  83006-55  83006-60  83007-30  83007-35  83007-40  83007-45  83007-50  83007-55  83008-30  83008-35  83008-40  83008-45  83008-50  83008-55  83008-80  82001-1    Catalog Numbers: LA-HSS0010  LA-HDOO01  LA-CTOO02  LA-PS0530  LA-PS0535  LA-PS0540  LA-PS0545  LA-PS0550  LA-PS0630  LA-PS0635  LA-PS0640  LA-PS0645  LA-PS0650  LA-PS0655  LA-PS0660  LA-PS0730  LA-PS0735  LA-PS0740  LA-PS0745  LA-PS0750  LA-PS0755  LA-PS0830  LA-PS0835  LA-PS0840  LA-PS0845  LA-PS0850  LA-PS0855  LA-PS0880  LA-SOO01   Lots Affected: All  
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 initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adve
FDA Determined
Cause 2		 Device Design
Action Alphatec Spine initiated recall by contacting customers via telephone and/or email on 05/06/2013. An Urgent Medical Device Recall Notification letter along with a response form were sent via FedEx to all affected accounts. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in Commerce 1,814
Distribution Nationwide Distribution.
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 = PHYGEN, LLC
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