medical Class II Updated 2025-03-12

Hiossen Inc. recalls Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.

Recalled Product

Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA505RV1

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: UDI-DI: 00810019241543 Lot# H4E22B111
View official government recall

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