Z-1273-2025Class II

ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support...

Name: Z-1273-2025 ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support...
Creator: Hiossen Inc.
Published: 2025-01-27
License: https://open.fda.gov/license/

Hiossen, Inc. / initiated 2025-01-27 / Open, Classified / root cause: packaging

FDA source

Hiossen Inc. began a recall of 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... on 2025-01-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1273-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-27
Posted: 2025-03-05
Recalling firm: Hiossen, Inc.
Product: 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
Product code: NHA Abutment, Implant, Dental, Endosseous
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
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Hoissen issued URGENT: MEDICAL DEVICE RECALL-CORRECTION letter on 1/27/25 via USPS Certified Mail. Letter states reason for recall, health risk and action to take. Immediate Actions to be taken by You, the clinician: 1. Do not use the affected devices 2. Quarantine (separate) the affected devices in a different location, away from normal stock room. 3.Immediately fill out the Acknowledgement and Receipt Form* (Fax: 267-795-7031 or Email: [email protected] ) *Response is required regardless if the devices have already been return or implanted 4. Return quarantined devices to the following address or contact your sales representative for assistance. ATTN: Peter Lee / Recall 85 Ben Fairless Dr. Fairless Hills, PA 19030 5. Replacement patient chart stickers will be provided so that you may include the corrected chart sticker in the patient s medical records as applicable. Hiossen has already deployed a permanent corrective action to address the issue described in this Recall Notice. Hiossen investigated and identified the source of the issue and has already implemented new procedures which eliminates the potential for further mis-labeling. Other Information If you need any further information or support concerning this recall/issue, please reach HIOSSEN: Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. Tel: 267-795-7031 Email: recall@hiossen
Quantity in commerce: 16 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Code: UDI-DI: 00814913026336 Lot# H4E20L090

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1273-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1271-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-05
Z-1272-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-05
Z-1273-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-05
Z-1274-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-05
Z-1275-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-05
Z-1276-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-05

Product code NHA

K130662Class IIEt Prosthetic SystemOsstem Implant Co., Ltd. / cleared 2014-01-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)