Z-2633-2023Class II

exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of...

Name: Z-2633-2023 exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of...
Creator: Exocad GmbH
Published: 2023-08-17
License: https://open.fda.gov/license/

Exocad GmbH / initiated 2023-08-17 / Open, Classified / root cause: software

FDA source

Exocad GmbH began a recall of exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the... on 2023-08-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2633-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-17
Posted: 2023-09-25
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.
Product code: LLZ System, Image Processing, Radiological
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
Root cause tag: software
FDA 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 in commerce: 96 licenses
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2633-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2633-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-25

Product code LLZ

K213302Class IIexoplanExocad GmbH / cleared 2022-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)