Fairless Hills, PA, United States
Hiossen Inc. recalls
2 recalls recorded since 2018, most recently on 27 January 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 January 2025
- Reason
- 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
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1273-2025, Z-1274-2025, Z-1271-2025, Z-1272-2025, Z-1275-2025, Z-1276-2025
- 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
- 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/Cat
- ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. GA4515MP Model/Catalog Number: ETRGA4515
- ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4537MP
- ET Rigid Abutment (Mini) Size: 4.5D 2.0G/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: ETRGA4524MP
- 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/Cat
Ongoing Class II Medical devices
- Recall started
- 6 April 2023
- Reason
- Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1604-2023
- ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.