CLASS II ONGOING Device recall · Reported 24 May 2023 · FDA Enforcement Report

ET III Nano-HA fixture System ET NH Dental Implant recalled by Hiossen

Hiossen is recalling ET III Nano-HA fixture System ET NH Dental Implant, distributed nationwide in the US. The recall was initiated on 6 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00814913023717 Lot Number: H1E22J263

Quantity recalled287 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1604-2023
FDA event ID: 92272
Recalling firm: Hiossen, Fairless Hills, PA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Apr 2023
FDA classified: 18 May 2023
Reported: 24 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Dental Devices

Timeline

6 Apr 2023	Recall initiated by company
18 May 2023	Classified by FDA	+42 days
24 May 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it 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

Which lots are affected?

UDI-DI: 00814913023717 Lot Number: H1E22J263

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Hiossen

All 7

Reported	Class	Recall	Company	Reason	Where
12 Mar 2025Device	CLASS II	Osstem Implant System - Abutment: ET Multi AbutmentSize recalled	Hiossen	Packaging Defects	Nationwide
12 Mar 2025Device	CLASS II	ET Rigid Abutment (Mini) Size: 4.5D/H 4.0H- Intended recalled by Hiossen	Hiossen	Packaging Defects	Nationwide
12 Mar 2025Device	CLASS II	ET Rigid Abutment (Mini) SIze: 4.5D/H 7.0H - Intended recalled	Hiossen	Packaging Defects	Nationwide
12 Mar 2025Device	CLASS II	ET Rigid Abutment (Mini) Size 4.5D/H 5.0H - Intended recalled by Hiossen	Hiossen	Packaging Defects	Nationwide
12 Mar 2025Device	CLASS II	Osstem Implant System - Abutment ET Multi Abutment Size recalled	Hiossen	Packaging Defects	Nationwide

Other Dental Devices recalls

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2 Sep 2026Device	CLASS II	Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled	Henry Schein	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	GM Helix Implant, Endosseous Dental Implant Article No. recalled	Straumann USA	Packaging Defects	Nationwide
15 Jul 2026Device	CLASS II	KL Owen Custom Orthodontic Solution recalled by Klowen Braces	Klowen Braces	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Straumann n!ce PMMA Full-arch Restoration recalled	Straumann USA	Other	8 states
6 May 2026Device	CLASS II	Straumann n!ce Zr, HT, Full-arch Restoration recalled	Straumann USA	Other	8 states