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U.S. Department of Health and Human Services

Class 2 Device Recall icotec VADER

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 Class 2 Device Recall icotec VADERsee related information
Date Initiated by FirmNovember 28, 2023
Date PostedJanuary 10, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0701-2024
Recall Event ID 93577
510(K)NumberK222789 
Product Classification bone cement, posterior screw augmentation - Product Code PML
ProductVADER pedicle system, torque wrench, Catalog Number 42-703
Code Information 220803-001, 220803-002, 220803-003
Recalling Firm/
Manufacturer		 Icotec Ag
Industriestrasse 12
Altstatten Sg Switzerland
Manufacturer Reason
for Recall		icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.
FDA Determined
Cause 2		Other
Actionicotec ag issued an URGENT Medical Device Recall notice to its consignees beginning on 11/28/2023 via email. The notice explained the problem with the device, the risk to health, and informed the medical facility that the affected product had been removed prior to the notice. Decision on whether patient-level follow-up is required should be made by the physician. Replacements will be provided where applicable. The firm expanded this recall on 12/27/2023 (notices delivered by US mail) to include additional lots and one additional product. Contact for questions: Laura Husken, laura.huesken@icotec.ch, Tel.: +41 78 438 78 73
DistributionUS: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA
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 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) Database510(K)s with Product Code = PML
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