Health product recall

Exoplan

Brand(s)
Last updated

Summary

Product
Exoplan
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Exoplan Not applicable 3.0 GALWAY 3.1 RIJEKA

Issue

During an update of data used in a library shipped with Exoplan or made available on the download portal of Exocad, it was found that the use of a specific combination of an implant, sleeve and drill in a surgical kit can result in a hole being drilled for the implant 2mm too deep.

In case an implant 260-340-256 of Bicon with a 4mm diameter and 6mm length is used in a fully-guided surgery procedure using a 4mm diameter Bicon sleeve it should only be possible to select a drill with 6mm  length. But erroneously uses an 8mm length drill (instead of 6mm length drill) from the surgical kit.

Recall start date: April 24, 2023

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, 6429

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73703

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