Exocad GmbH: 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 o

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

Details from the source

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 Distribution: Worldwide distribution - US Nationwide and the country of Canada. Quantity: 96 licenses Lot/code info: UDI-DI: (01)4260521365026(10)A03B01E8439 (US) (01)4260521365026(10)A03B01E8588 (SR1 US) (01)4260521365026(10)A03B01E8606 (SR1 US offline) Software xoplan 3.1 Rijeka

UPC codes

4260521365026

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.