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: ETRGA4515MP
Reported: March 12, 2025 Initiated: January 27, 2025 #Z-1271-2025
Product Description
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: ETRGA4515MP
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
Details
- Recalling Firm
- Hiossen Inc.
- Units Affected
- 48
- Distribution
- US Nationwide distribution.
- Location
- Fairless Hills, PA
Frequently Asked Questions
What product was recalled? ▼
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: ETRGA4515MP. Recalled by Hiossen Inc.. Units affected: 48.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on March 12, 2025. Severity: Moderate. Recall number: Z-1271-2025.
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