Notification – Action Required
Dear Sales Partner,
We have to inform you of two Field Safety Notices related to exoplan software and related libraries that require immediate action on your part.
- Software issue with Straumann BLX/TLX implant library and drill protocol
It has come to our attention that a software issue incorrectly filters compatibility information contained in the library Straumann® BLX/TLX implants and the affected Straumann® step-by-step full drill protocol libraries where multiple sub-full drill protocols exist, e.g., hard-, medium- and soft-bone protocols. To correct the issue and to ensure that all end users of exoplan 3.1 Rijeka are reached and take appropriate action, we are providing an updated exoplan version, and will disable all previous exoplan 3.1 Rijeka versions on October 19, 2023.
Please notify your customers who are using exoplan 3.1 Rijeka immediately, and provide them with the respective update. Please download and read the Field Safety Notice and forward the FSN to your customers by email.
Who is affected?
Only exoplan 3.1 Rijeka 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.
How should users react?
Users should not use the affected libraries — see section “Affected libraries” in the Field Safety Notice — with exoplan 3.1 Rijeka until the new version and updated libraries are installed. Existing designs of surgical guides using the affected libraries should not be used. All users of exoplan 3.1 Rijeka must update to the latest version, available for download on our download server.
Where can I get this new version?
As usual you can download the software and the detailed release notes in the secure area on our website. Download the zip file that includes the software here:
What other actions were taken?
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.
For users who have previously installed 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 notified by this warning should click “Cancel” and not “Continue”.
New library versions of Straumann® BLX/TLX/VeloDrill libraries have been released.
End users can download the new libraries at https://exocad.com/integration/exoplan-library-integration or use exocad Library Manager from within exoplan.
2. CAMLOG_sleeve and Steco_StecoGuide_Compatible_Camlog_sleeve library set update
It came to our attention that in the case a CAMLOG® Screw-Line Promote® guide-screw-mounted implant is used in a guided surgery procedure using a CAMLOG® or Steco sleeve, the resulting guide allows a drill hole which is 1 mm deeper than expected due to a dimensional error in the affected libraries.
Please download and read the Field Safety Notice.
Note: The issue relates only to the CAMLOG® Screw-Line Promote® guide-screw-mounted implant line. Other CAMLOG® libraries (e.g. Promote® Plus implants) and any other exoplan library package can still be used.
The affected CAMLOG® and Steco 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.
If the user tries to select a component in the affected library, the user receives a message stating that a library in the planning is “Unsigned”. Users notified by this warning should click “Cancel” and not “Continue”.
New library versions of CAMLOG_sleeve and Steco_StecoGuide_Compatible_Camlog_sleeve have been released.
End users who want to plan CAMLOG® Screw-Line Promote® guide-screw-mounted implants should download the corrected library package:
End users can also download the new libraries at https://exocad.com/integration/exoplan-library-integration or use exocad Library Manager from within exoplan.
Patient safety is our priority. exocad has no known information relating to any patient injury that has happened in such a case.
As we work closely with all relevant regulatory bodies and authorities to provide transparent reporting on this incident, we ask you to notify your exoplan customers immediately.
If you have any further questions, please contact our Customer Service team: firstname.lastname@example.org.
Your exocad Customer Service team