Z-1274-2025 Class II Ongoing

Recalled by Hiossen Inc. — Fairless Hills, PA

Recall Details

Product Type
Devices
Report Date
March 12, 2025
Initiation Date
January 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide distribution.

Code Information

Lot Code: UDI-DI: 00810019241529 Lot# H4E21D092