Public recall detail

Exoplan

2023-05-25

medium
Recall Safety notice
Quick summary

Quick summary: Exoplan. Date: 2023-05-25.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Exoplan. Date: 2023-05-25.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandExocad GmbH
ProductExoplan
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73703

Affected products

ProductExoplan
LotNot applicable
Model3.0 GALWAY 3.1 RIJEKA
Serial numberNot applicable
DescriptionExoplan

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesExocad GmbH Rosa-Parks-Str.2, Darmstadt, Germany, 6429
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73703
Background{}
CompaniesExocad GmbH Rosa-Parks-Str.2, Darmstadt, Germany, 6429
AudiencesHealthcare
Source updated2023-05-25

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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