Hiossen Inc. recalls Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implan…

Recall date

January 27, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1274-2025

FDA classification

Class II

Brand / firm

Hiossen Inc.

Sold / distributed

US Nationwide distribution.

Why it was recalled

Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1