Device recall
Z-1276-2025: Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment…
FDA device recall · Class II · Hiossen Inc.
Key facts
| Recall number (Z-number) | Z-1276-2025 |
|---|---|
| Recall event | 96178 |
| 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 |
| Product code | NHA |
| Recalling firm | Hiossen Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161689 |
| FEI number | 3007135442 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database