Recall Monitor
Health Products

Exoplan

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Exoplan
Issue: Medical devices - Performance
What to do: DO NOT USE AFFECTED LIBRARY AS PER THE FIELD SAFETY NOTICE.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
ExoplanEB8633 and higher04260521365026

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.

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