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U.S. Department of Health and Human Services

Class 2 Device Recall SICAT IMPLANT V2.0

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  Class 2 Device Recall SICAT IMPLANT V2.0 see related information
Date Initiated by Firm July 15, 2020
Create Date September 10, 2020
Recall Status1 Open3, Classified
Recall Number Z-2951-2020
Recall Event ID 86165
510(K)Number K192348  
Product Classification System, image processing, radiological - Product Code LLZ
Code Information V2.0
Recalling Firm/
Brunnenallee 6
Bonn Germany
Manufacturer Reason
for Recall
A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.
FDA Determined
Cause 2
Software design
Action On 07/15/2020 customer notification letter was sent to all users/customers who have the 2.0 version of the software installed in the system. These users are instructed to only use the system for specific cases as defined in the field safety notice. The firm plans on implementing a new software version in July 2020 to correct the issues found.
Quantity in Commerce 853 units
Distribution Worldwide 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 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 = LLZ and Original Applicant = SICAT GmbH & Co. KG