• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Leucadia Autolok" Polyaxial Pedicle Screw System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Leucadia Autolok" Polyaxial Pedicle Screw System see related information
Date Initiated by Firm May 06, 2013
Date Posting Updated 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
-
-