Osstell® Smartpeg Type 101-104
Brand(s)
Summary
Contact the manufacturer Osstell has a new IFU under implementation and has initiated a design change.
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
Osstell AB
Stampgatan 14, Goteborg, Sweden, 41101
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