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U.S. Department of Health and Human Services

Class 2 Device Recall Exocad

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  Class 2 Device Recall Exocad see related information
Date Initiated by Firm August 17, 2023
Date Posted September 25, 2023
Recall Status1 Open3, Classified
Recall Number Z-2633-2023
Recall Event ID 92921
510(K)Number K213302  
Product Classification System, image processing, radiological - Product Code LLZ
Product exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy.
Code Information UDI-DI: (01)4260521365026(10)A03B01E8439 (US) (01)4260521365026(10)A03B01E8588 (SR1 US) (01)4260521365026(10)A03B01E8606 (SR1 US offline) Software xoplan 3.1 Rijeka
Recalling Firm/
Manufacturer		 Exocad GmbH
Julius-Reiber-Str. 37
Darmstadt Germany
Manufacturer Reason
for Recall		 A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Protocol export functionality of exoplan 3.1 Rijeka. When a guided surgery treatment approach is selected, along with a Step-by-Step Full Drill Protocol export implant library, exoplan software does not filter out unsupported sleeve height positions for a particular sub-full drill protocol and instead shows ALL possible sleeve height positions for all sub-full drill protocols. The use of an improper sleeve height position in a surgical guide could result in patient injury
FDA Determined
Cause 2		 Software design
Action Exocad issued Field Safety Notification via email on 8/17/23 to Distributors and End Users. Letter states reason for recall, health risk and action to take: Please download and read the Field Safety Notice and the exocad Recall Notice. As required by the Field Safety Notice, please notify your customers who are using exoplan 3.1 Rijeka, immediately. Only exoplan 3.1 users who use or are planning to use a guided surgical treatment approach with Straumann¿ BLX/TLX implants and Straumann¿ BLX/TLX /VeloDrill libraries with step-by-step full drill protocol export are affected by this Field Safety Notice and recommended actions. Users should not use the affected libraries see section Affected libraries in the Field Safety Notice with exoplan 3.1 Rijeka until a new exoplan 3.1 Rijeka version and updated libraries are released and made available for download at Recall of exoplan 3.1 Rijeka: end user noti¿ ication required immediately 1 of 3 20/08/2023, 21:24 https://exocad.com/integration/exoplan-library-integration. We will inform you, as soon as a new version of exoplan 3.1 Rijeka is available. Please contact your exoplan 3.1 Rijeka end users and forward the FSN to them by email. The end user should reply by email to you and servicenorthamerica@ exocad.com even if they are not affected, with the con¿ rmation requested in Annex 2 of the FSN. Within 14 days, we ask you to complete and return Annex 3 of the FSN to the same email address. The affected Straumann¿ libraries were removed from the download server and blacklisted on the exocad server. Users are no longer able to see or download the affected libraries. As a result of the blacklisting, if the user tries to select a component in the selected full drill protocol library, the user receives a message stating that a library in the planning is unsigned. Users noti¿ ed by this warning should click cancel and not continue. If you have any further questions, please contact our Customer Service team at service-
Quantity in Commerce 96 licenses
Distribution Worldwide distribution - US Nationwide and the country of Canada.
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 = exocad GmbH
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