Company: Exocad GmbH
Date of Enforcement Report:9/25/2023
Class II
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.
Recall Number:
Z-2633-2023
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
RECALLING FIRM/MANUFACTURER:
Exocad GmbH
VOLUME OF PRODUCT IN COMMERCE:
96 licenses
DISTRIBUTION:
Worldwide distribution – US Nationwide and the country of Canada.
