CLASS II ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report
Osstem Implant System - Abutment ET Multi Abutment Size recalled
Hiossen is recalling Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D/H- Abutment is intended for, distributed nationwide in the US. The recall was initiated on 27 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1274-2025
- FDA event ID
- 96178
- Recalling firm
- Hiossen, Fairless Hills, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jan 2025
- FDA classified
- 5 Mar 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Dental Devices
Timeline
| 27 Jan 2025 | Recall initiated by company | |
| 5 Mar 2025 | Classified by FDA | +37 days |
| 12 Mar 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot Code: UDI-DI: 00810019241529 Lot# H4E21D092
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 96178This product is part of a recall event; the main page for the event is ET Rigid Abutment (Mini) SIze: 4.5D/H 4.0H - Intended recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ET Rigid Abutment (Mini) SIze: 4.5D/H 4.0H - Intended recalled | Hiossen | Packaging Defects | Nationwide | |
| CLASS II | ET Rigid Abutment (Mini) Size 4.5D/H 5.0H - Intended recalled by Hiossen | Hiossen | Packaging Defects | Nationwide | |
| CLASS II | ET Rigid Abutment (Mini) SIze: 4.5D/H 7.0H - Intended recalled | Hiossen | Packaging Defects | Nationwide | |
| CLASS II | ET Rigid Abutment (Mini) Size: 4.5D/H 4.0H- Intended recalled by Hiossen | Hiossen | Packaging Defects | Nationwide | |
| CLASS II | Osstem Implant System - Abutment: ET Multi AbutmentSize recalled | Hiossen | Packaging Defects | Nationwide |
More recalls from Hiossen
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Osstem Implant System - Abutment: ET Multi AbutmentSize recalled | Hiossen | Packaging Defects | Nationwide |
| Device | CLASS II | ET Rigid Abutment (Mini) Size: 4.5D/H 4.0H- Intended recalled by Hiossen | Hiossen | Packaging Defects | Nationwide |
| Device | CLASS II | ET Rigid Abutment (Mini) SIze: 4.5D/H 7.0H - Intended recalled | Hiossen | Packaging Defects | Nationwide |
| Device | CLASS II | ET Rigid Abutment (Mini) Size 4.5D/H 5.0H - Intended recalled by Hiossen | Hiossen | Packaging Defects | Nationwide |
| Device | CLASS II | ET Rigid Abutment (Mini) SIze: 4.5D/H 4.0H - Intended recalled | Hiossen | Packaging Defects | Nationwide |
Other Dental Devices recalls
All 426| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |