Recall Z-2633-2023 ยท LLZ System, Image Processing, Radiological
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.
| Date | Sep 25, 2023 (initiated Aug 17, 2023) |
| Status | Open, Classified |
| 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 Not |
| Quantity | 96 licenses |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213302 | exoplan Exocad GmbH, May 3, 2022 |