Exocad GmbH recalls exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implan

Recalled October 4, 2023 · FDA recall Z-2633-2023 · Exocad

Hazard

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 · FDA Class II

Units

96 licenses

Sold at

Worldwide distribution - US Nationwide and the country of Canada.

Description

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(s)

Exocad GmbH

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →