Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for u...
FDA Device Recall #Z-1276-2025 — Class II — January 27, 2025
Recall Summary
| Recall Number | Z-1276-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 27, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hiossen Inc. |
| Location | Fairless Hills, PA |
| Product Type | Devices |
| Quantity | 119 units |
Product Description
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
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
Lot Code: UDI-DI: 00810019241543 Lot# H4E22B111
Other Recalls from Hiossen Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1273-2025 | Class II | ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H... | Jan 27, 2025 |
| Z-1274-2025 | Class II | Osstem Implant System - Abutment ET Multi Abut... | Jan 27, 2025 |
| Z-1271-2025 | Class II | ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H ... | Jan 27, 2025 |
| Z-1272-2025 | Class II | ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H... | Jan 27, 2025 |
| Z-1275-2025 | Class II | ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H... | Jan 27, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.