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Exoplan

Official notice

25 May 2023

Last checked

25 May 2023

Medium riskHealth Canada
Watch Exocad

An official Health Canada notice concerns Exoplan. 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 Published 2023-05-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73703

Official notice

2023-05-25

The hazard

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

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

73703

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Affected products

Product 1

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

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Exocad, Exoplan

Manufacturer

Not provided

Phone

Not provided

Brand: Exocad, Exoplan.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73703

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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