ET III Nano-HA fixture System ET NH Dental Implant Model #… recallZ-1604-2023 · Hiossen Inc. · initiated Apr 6, 2023

Class II Open, Classified All recalls posted in May 2023

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Hiossen Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling Change Control

What the company is doing

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]

Recall details

Recall number: Z-1604-2023
Recall class: Class II
Status: Open, Classified
Initiated by the company: Apr 6, 2023
Posted by the FDA: May 18, 2023
Recalling firm: Hiossen Inc.
Quantity: 287 units
Product code: DZE
FDA submissions: K151626
Distribution: US Nationwide Distribution

Product description

ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B

Code information (models, lots, serial numbers)

UDI-DI: 00814913023717 Lot Number: H1E22J263

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

ET III Fixture NH Regular Pre-Mounted AET3R5010B
Hiossen, Inc. · Implant, Endosseous, Root-Form
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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