Z-1275-2025 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

ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4524MP

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: 00814913026312 Lot# H4E21G062