Recall Z-1272-2025— Hiossen Inc.

Name: FDA recall Z-1272-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-27

Class II · Ongoing

Class II FDA medical device recall by Hiossen Inc., initiated 2025-01-27. It names one FDA 510(k) clearance: K130662. Product: ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4537MP. Reason: 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.

Recalling firm: Hiossen Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-01-27
Firm location: Fairless Hills, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K130662 — ET PROSTHETIC SYSTEMOsstem Implant Co., Ltd.·cleared 2014-01-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4537MP

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.