Hiossen Inc.: Medical Device Recall in 2025 - (Recall #: Z-1271-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. GA4515MP Model/Catalog Number: ETRGA4515MP

Product Classification:

Class II

Date Initiated: January 27, 2025

Date Posted: March 12, 2025

Recall Number: Z-1271-2025

Event ID: 96178

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

Status: Ongoing

Product Quantity: 48

Code Information:

UDI-DI: 00814913026350 Lot# H4E20K117

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated