exoplan version 3.1 Rijeka Software -A medical software… recallZ-2633-2023 · Exocad GmbH · initiated Aug 17, 2023

Why it was recalled

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 root cause category: Software design

What the company is doing

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-

Recall details

Recall number

Z-2633-2023

Status

Open, Classified

Initiated by the company

Aug 17, 2023

Posted by the FDA

Sep 25, 2023

Recalling firm

Exocad GmbH

Quantity

96 licenses

Product code

LLZ

FDA submissions

K213302

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Product description

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• exoplan 3.1 Rijeka

  exocad GmbH · System, Image Processing, Radiological
  1 recall0 reports