Health product recall

Exoplan

Brand(s)
Last updated

Summary

Product
Exoplan
Issue
Medical devices - Performance
What to do

DO NOT USE AFFECTED LIBRARY AS PER THE FIELD SAFETY NOTICE.

Audience
Healthcare

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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Exocad Gmbh

Rosa-Parks-Str.2, Darmstadt, Germany, 64295

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82095

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