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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 VADERsee related information
Date Initiated by FirmNovember 03, 2022
Date PostedDecember 19, 2022
Recall Status1 Terminated 3 on September 10, 2026
Recall NumberZ-0728-2023
Recall Event ID 91174
510(K)NumberK190545 K193423 K200596 
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
ProductVADER 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
FEI Number 3006493760
Recalling Firm/
Manufacturer		 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
ActionIcotec 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 Commerce6 devices
DistributionUS Nationwide distribution in the state of GA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NKB
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