PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: October 4, 2023 Initiated: August 17, 2023 #Z-2633-2023

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.

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

Details

Recalling Firm
Exocad GmbH
Units Affected
96 licenses
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Location
Darmstadt, N/A

Frequently Asked Questions

What product was recalled?
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.. Recalled by Exocad GmbH. Units affected: 96 licenses.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Devices on October 4, 2023. Severity: Moderate. Recall number: Z-2633-2023.