Exocad GmbH: 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.

Recall number

Z-2633-2023

Recalling firm

Exocad GmbH

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.

Status

Open, Classified

Initiated

2023-08-17

Posted

2023-09-25

Terminated

not on file

Reason

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

Root cause

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

96 licenses

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Lot, serial or model codes

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

510(k) numbers

["K213302"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

3011521456

Firm city

Darmstadt

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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