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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 Posted May 28, 2013
Recall Status1 Terminated 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = PHYGEN, LLC
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