Dental implant abutments recalled for incorrect packaging labels
Hiossen has recalled ET Rigid Abutment dental implant components because stickers in the packaging mislabel whether products are Mini or Regular versions. Incorrect identification could affect proper implant installation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving packaging labeling errors with no reported injuries or illnesses. The hazard is product misidentification, representing a risk of improper clinical use, which meets the criteria for Moderate severity per the rubric.
Plain-English summary
Hiossen Inc. is recalling ET Rigid Abutment (Mini) dental implant components due to labeling errors on patient chart stickers included in the product packaging. The affected product lot includes 48 units distributed nationwide.
The issue is that stickers in the packaging incorrectly identify ET Rigid Abutments as Regular version when they are actually Mini version, and incorrectly identify ET Multi Abutments as Mini version when they are actually Regular version. This labeling confusion could lead to incorrect product identification and improper installation during dental implant procedures.
Dental professionals who received this product should independently verify the actual product version before clinical use. If you have received product with lot number H4E20K117 and UDI-DI 00814913026350, contact Hiossen Inc. for replacement or guidance. No injuries or illnesses have been reported related to this labeling error.
The recalled product
- Product
- 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
- Manufacturer
- Hiossen Inc.
- Affected units
- 48
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00814913026350 Lot# H4E20K117
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Hiossen Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Hiossen Inc.
See all →- HighOsstem dental implant abutments mislabeled on patient chart stickers
FDA (Devices) · 2025-03-12
- ModerateDental Abutments Recalled for Incorrect Version Identification Stickers
FDA (Devices) · 2025-03-12
- ModerateHiossen Dental Abutments Misidentified on Patient Chart Stickers
FDA (Devices) · 2025-03-12
- ModerateDental abutment implants recalled for incorrect patient chart stickers
FDA (Devices) · 2025-03-12
- ModerateET Rigid and Multi Dental Abutments Recalled for Incorrect Identification Stickers
FDA (Devices) · 2025-03-12
Same hazard · mislabeling
See all →- ModerateOrthofix MINIRAIL External Fixation Devices Incorrectly Labeled
FDA (Devices) · 2026-07-22
- ModerateWise Onion Rings recalled for undeclared food color additives
FDA (Food) · 2026-07-15
- HighBakr Brown Butter Chocolate Chunk Cookie Dough Recalled for Undeclared Soy
FDA (Food) · 2026-07-15
- HighStapes prosthesis pistons carry an incorrect functional length on labeling
FDA (Devices) · 2026-06-10
- HighMedline eye trays contain insulin syringes labeled as tuberculin syringes
FDA (Devices) · 2026-06-03
Similar recalls
- ModerateDental implant system recalled for incorrect package length labeling
FDA (Devices) · 2023-05-24
- ModerateStraumann Recalls Neodent GM Mini Conical Abutments Due to Label Mismatch
FDA (Devices) · 2018-11-21
- ModerateBiomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
FDA (Devices) · 2016-12-28
- HighDental abutment recall due to incorrect product packaging and labeling
FDA (Devices) · 2024-07-17
- HighDental implant kits recalled for mislabeled implant dimensions
FDA (Devices) · 2022-01-26
- LowBiomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect
FDA (Devices) · 2016-12-28