ET Multi Abutment ETMTA505RRecalls & reported problems
Hiossen, Inc. · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K161689); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jan 27, 2025Open, Classified
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
Z-1276-2025 · Root cause: Under Investigation by firm · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K161689. One submission often covers many models, so check the product and lot details in each record.
- Z-1274-2025 · Jan 27, 2025 · Open, ClassifiedOsstem 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 crow
Other Abutment, Implant, Dental, Endosseous devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.