ET Rigid Abutment — Class II medical device recall Z-1273-2025
Ongoing recall by Hiossen Inc., reported 2025-03-12, distributed nationwide. Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular ve
| Recall number | Z-1273-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hiossen Inc., Fairless Hills, PA, United States |
| Recall initiated | 2025-01-27 |
| Classified | 2025-03-05 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 16 units |
| UPC / GTIN / UDI-DI | 00814913026336 |
| Lot numbers | H4E20L090 |
| Model numbers | ETRGA4544MP |
Product
ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/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: ETRGA4544MP
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1273-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.