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U.S. Department of Health and Human Services

Class 2 Device Recall VADER

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  Class 2 Device Recall VADER see related information
Date Initiated by Firm November 03, 2022
Date Posted December 19, 2022
Recall Status1 Open3, Classified
Recall Number Z-0728-2023
Recall Event ID 91174
510(K)Number K190545  K200596  K193423  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
Product VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Code Information UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045
Recalling Firm/
Icotec Ag
Industriestrasse 12
Altstatten Sg Switzerland
Manufacturer Reason
for Recall
During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Icotec issued a Field Action Notice to its consignee on 11/03/2022 by email. The notice explained the issue and that XXXX. The firm followed with an email to inform the consignee of their intent to recall the device. The notice requested the return of the device from the field. The firm will be replacing the devices.
Quantity in Commerce 6 devices
Distribution US Nationwide distribution in the state of GA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = icotec ag