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Exoplan

Official notice

20 May 2026

CriticalHealth Canada

An official Health Canada notice concerns Exoplan. 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. Published 2026-05-20.

What to do now

Do not use affected library as per the field safety notice.

Recall number

82095

Official notice

2026-05-20

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

EB8633 and higher

Skus

04260521365026

Other

RA RA-82095

Model Numbers

04260521365026

Recall Numbers

82095

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Affected products

Product 1

Lot or serial number - EB8633 and higher, Model or catalogue number - 04260521365026

Risk / hazard

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.

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Exocad.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

82095

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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