Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-1275-2025

U.S. FDA — Device Enforcement · United States · 2025-01-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1275-2025
Date of alert
2025-01-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hiossen Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00814913026312
Reported risk: 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
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.