FDA Device recall Z-1271-2025
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…
- FDA Device
- Class II
- ongoing
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class II recall of 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… by Hiossen, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1271-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-27 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Hiossen |
| Distribution | US |
Product
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
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
Identifiers
| code_info | UDI-DI: 00814913026350 Lot# H4E20K117 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1271-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.