Exoplan
Brand(s)
Summary
DO NOT USE AFFECTED LIBRARY AS PER THE FIELD SAFETY NOTICE.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Exoplan | EB8633 and higher | 04260521365026 |
Issue
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.
Additional information
Details
Exocad Gmbh
Rosa-Parks-Str.2, Darmstadt, Germany, 64295
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