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ET Rigid Abutment ETRGA4524MPRecalls & reported problems

Hiossen, Inc. · Class 2 · Implant

All models of ET Rigid Abutment (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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.

3 other recalls cover devices cleared under the same FDA submission (K130662); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Jan 27, 2025Class IIOpen, 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-1275-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130662. One submission often covers many models, so check the product and lot details in each record.

  • Z-1272-2025 · Jan 27, 2025 · Open, Classified
    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. Mo
  • Z-1271-2025 · Jan 27, 2025 · Open, Classified
    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. GA
  • Z-1273-2025 · Jan 27, 2025 · Open, Classified
    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. Mo

Other Abutment, Implant, Dental, Endosseous devices

All Abutment, Implant, Dental, Endosseous devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page