The Recall Desk
HighFDA (Devices)·Z-2633-2023·Announced 2023-10-04

exoplan 3.1 Dental Software Filtering Error Affects Surgical Guide Planning

Dental planning software exoplan 3.1 contains a filtering error that may display all surgical guide options instead of only supported ones, potentially causing patient injury.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with a software defect that could cause patient injury through improper surgical guidance. No illnesses or injuries have been reported. As a risk-of-harm product without reported adverse events, this meets the High severity criterion.

Plain-English summary

exoplan version 3.1 Rijeka is a medical software application developed by Exocad GmbH that helps dentists plan dental implant placement by visualizing the implant's position within patient images. The software includes export functionality for Step-by-Step Full Drill Protocol procedures used in guided surgical planning.

A software library filtering error has been identified in this version. When users select a guided surgery treatment approach combined with a Step-by-Step Full Drill Protocol export, the software fails to properly filter out unsupported sleeve height positions. Instead of displaying only the appropriate options for a specific sub-full drill protocol, the software shows all possible sleeve height positions across all sub-full drill protocols.

Using an improper sleeve height position in a surgical guide could result in patient injury. This recall affects 96 licenses distributed worldwide, including throughout the United States and Canada.

Users of exoplan version 3.1 Rijeka should contact Exocad GmbH for guidance on this issue and potential software updates or corrections. Healthcare providers and dental practices using this software should review their recent surgical plans prepared with this software.

The recalled product

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.
Manufacturer
Exocad GmbH
Category
Medical Device — Dental / Surgical Planning Software
Hazard
  • software-error
  • surgical-guidance-error
  • patient-injury-risk

Distribution

Distributed nationwide across the United States.

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