Z-1604-2023Class II

ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #...

Name: Z-1604-2023 ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #...
Creator: Hiossen Inc.
Published: 2023-04-06
License: https://open.fda.gov/license/

Hiossen, Inc. / initiated 2023-04-06 / Open, Classified / root cause: labeling and UDI

FDA source

Hiossen Inc. began a recall of ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B on 2023-04-06. FDA classified it as Class II and gives the reason as "Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1604-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-06
Posted: 2023-05-18
Recalling firm: Hiossen, Inc.
Product: ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Hoissen Inc. initial contact verbally through sales rep. on April 7, 2023 and by "URGENT: MEDICAL DEVICE RECALL" Letter via Mail & email on 04/19/2023. Letter states reason for recall, health risk and action to take: 1. Do not use the Recall Implants. 2. Quarantine (separate) the Recall Implants 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 Recall Implants have already been return or implanted. 4. Returned the Recall Implant(s) as Unusable Returns to Hiossen QA** **Contact your sales representative for assistance. 5. Replacement devices are available for delivery. 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: [email protected]
Quantity in commerce: 287 units
Distribution: US Nationwide Distribution
Product codes and lots: UDI-DI: 00814913023717 Lot Number: H1E22J263

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1604-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1604-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-18

Product code DZE

K151626Class IIET III Bio-SA Fixture SystemHiossen, Inc. / cleared 2016-07-21

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)