CanadaExoplan software (Exoplan version 3.1) from Exocad GmbH, using specific Straumann surgical protocol libraries and identified by lot/serial EB8633 and higher and catalogue number 04260521365026, is affected. An error can display an incorrect drill key in two consecutive final drilling steps for certain implant/sleeve/workflow selections, which may result in drilling up to 2 mm deeper than intended and possible injury; DO NOT USE AFFECTED LIBRARY AS PER THE FIELD SAFETY NOTICE.
What's being recalled
Companies: Exocad Gmbh, Rosa-Parks-Str.2, Darmstadt, Germany, 64295.
How to identify it
Affected products: Exoplan; Lot or serial number: EB8633 and higher; Model or catalogue number: 04260521365026
The hazard
During internal testing of libraries an error was identified within specific Straumann surgical protocol libraries used with Exoplan version 3.1. Under certain implant/sleeve/workflow selections, the protocol output displays an incorrect instrument combination in the final drilling steps. In two consecutive protocol steps an incorrect drill key is displayed, which may result in a drilling depth up to 2 mm deeper than intended. This may lead to unintended injury depending on anatomical conditions and clinical use. The deviation is limited to specific implant/sleeve/workflow selections and does not affect all protocol configurations.
What to do
DO NOT USE AFFECTED LIBRARY AS PER THE FIELD SAFETY NOTICE.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)