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Osstell® smartpeg type 101-104

Official notice

17 Jul 2025

Last checked

17 Jul 2025

Medium riskHealth Canada

An official Health Canada notice concerns Osstell® smartpeg type 101-104. If not correctly used with a reference measurement on implant level. The measurement on abutment can indicate a false high ISQ value. This can influence the clinician to take the wrong decision and load the implant too early, in the extension potentially resulting in implant failure for the patient. Recall start date: May 23, 2025 Published 2025-07-17.

What to do now

Contact the manufacturer Osstell has a new IFU under implementation and has initiated a design change.

Recall number

77736

Official notice

2025-07-17

The hazard

If not correctly used with a reference measurement on implant level. The measurement on abutment can indicate a false high ISQ value. This can influence the clinician to take the wrong decision and load the implant too early, in the extension potentially resulting in implant failure for the patient. Recall start date: May 23, 2025

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.

Recall Numbers

77736

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Affected products

Product 1

Affected products - Osstell® Smartpeg Type 101-104, Lot or serial number - Not applicable., Model or catalog number - 100766

Product 2

Affected products - Osstell® Smartpeg Type 101-104, Lot or serial number - Not applicable., Model or catalog number - 100767

Product 3

Affected products - Osstell® Smartpeg Type 101-104, Lot or serial number - Not applicable., Model or catalog number - 100769

Product 4

Affected products - Osstell® Smartpeg Type 101-104, Lot or serial number - Not applicable., Model or catalog number - 100768

Risk / hazard

If not correctly used with a reference measurement on implant level. The measurement on abutment can indicate a false high ISQ value. This can influence the clinician to take the wrong decision and load the implant too early, in the extension potentially resulting in implant failure for the patient. Recall start date: May 23, 2025

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

Manufacturer

Not provided

Phone

Not provided

Brand: Osstell, Osstell® Smartpeg Type 101-104.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77736

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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