Osstell® Smartpeg Type 101-104
Brand(s)
Last updated
Summary
Product
Osstell® Smartpeg Type 101-104
Issue
Medical devices - Performance
What to do
Contact the manufacturer Osstell has a new IFU under implementation and has initiated a design change.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Osstell® Smartpeg Type 101-104 | Not applicable. | 100766 |
| Osstell® Smartpeg Type 101-104 | Not applicable. | 100767 |
| Osstell® Smartpeg Type 101-104 | Not applicable. | 100769 |
| Osstell® Smartpeg Type 101-104 | Not applicable. | 100768 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
Companies
Osstell AB
Stampgatan 14, Goteborg, Sweden, 41101
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77736
Get notified
Receive notifications for new and updated recalls and alerts by category.