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

Recall date

August 17, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2633-2023

FDA classification

Class II

Brand / firm

Exocad GmbH

Sold / distributed

Worldwide distribution - US Nationwide and the country of Canada.

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.