Hiossen Inc.: Medical Device Recall in 2023 - (Recall #: Z-1604-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: April 6, 2023
Date Posted: May 24, 2023
Recall Number: Z-1604-2023
Event ID: 92272
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

Status: Ongoing
Product Quantity: 287 units
Code Information:

UDI-DI: 00814913023717 Lot Number: H1E22J263

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated