Osstem Implant System — Class II medical device recall Z-1276-2025
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-1276-2025 |
|---|---|
| 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 | 119 units |
| UPC / GTIN / UDI-DI | 00810019241543 |
| Lot numbers | H4E22B111 |
| Model numbers | ETMTA505RV1 |
Product
Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA505RV1
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-1276-2025. 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.